Overview

Click on the categorized tabs to view studies at Penn State Health Milton S. Hershey Medical Center.

Contact

For more information about heart and vascular clinical trial opportunities at Hershey Medical Center:

Phone: 717-531-5967

Email: PSHVIresearchcoordinators@pennstatehealth.psu.edu

Heart failure and heart transplant

AIM-Higher

Purpose: To evaluate the safety and efficacy of cardiac contractility modulation therapy (CCM) in patients with symptomatic heart failure with left ventricle ejection fraction between 40 and 60%.

Principal investigator: John Boehmer, MD (Research profile | Find a Doctor profile)

Major inclusion criteria:

• Diagnosed with symptomatic heart failure
• Left ventricle ejection fraction greater than or equal to 40 and less than or equal to 60%
• Heart failure hospitalization within 12 months prior to study consent OR urgent heart failure visit requiring IV therapy during the six months prior to study consent, AND elevated BMI-adjusted natriuretic peptide values OR if there is no heart failure hospitalization within 12 months prior to study consent OR an urgent heart failure visit requiring IV therapy within six months prior to study consent, must have an elevated BMI-adjusted natriuretic peptide value
• Subjects must be on stable, scheduled oral loop diuretic treatment for at least 30 days prior to study consent

Major exclusion criteria:

• Receiving cardiac resynchronization therapy (CRT)
• Exercise tolerance limited by a condition other than heart failure
• Dialysis (permanent) or GFR less than 20 ml/min/1.73m2

Learn more: View this trial on clinicaltrials.gov.

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Lux Dx Trends

Principal investigator: John Boehmer, MD (Research profile | Find a Doctor profile)

Purpose: The primary purpose of this study is to collect physiological measurement data and HF (Heart Failure) event data that will be used to design and develop new diagnostic features for insertable cardiac monitor (ICM) systems. Enrollment into this study requires that an individual undergoes a LUX-Dx ICM (insertable cardiac monitor) insertion procedure.

Major inclusion criteria:

• NYHA class II or III
• Heart failure hospitalization in previous 12 months and/or elevated NTproBNP (N-terminal pro b-type natriuretic peptide)

Major exclusion criteria:

• Currently implanted with another medical device (ICD/CRT/LVAD)
• Diagnosed with amyloidosis or hypertrophic cardiomyopathy

Learn more: View this trial on clinicaltrials.gov.

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OPT-BB Women Study

Primary Investigator: Nandini Nair, MD (Research profile | Find a Doctor profile)
Purpose: The primary objective of this pilot study is to document the percentage achievement in effective heart rate (HR) control (median nighttime HR < 70 bpm) during wearable cardioverter defibrillator (WCD). Participants will include a cohort of female patients with cardiomyopathy, in an outpatient setting, using continuous heart rate trends data from the WCD to optimize Beta Blocker dosage, as compared to a prior historical control.

Major inclusion criteria:

• Female patients, 18 years or older, with ischemic or non-ischemic cardiomyopathy diagnosed within 30 days and an EF less than or equal to 35% at the time of WCD prescription.
• Patients prescribed the WCD for an intended 90 ± 14 days of use and have not been prescribed and wearing the device for more than 14 days prior to consent.

Major exclusion criteria:

• Permanent atrial fibrillation diagnosis, has a pacemaker, has had or currently has an implantable cardioverter defibrillator (ICD), or has known congenital or inherited heart disease
• Patients with known contraindication or intolerance to beta-blocker therapy
• Patients life expectancy is less than 3 months, currently pregnant, or participating in another clinical trial

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Optimizer Smart PAS

Principal investigator: John Boehmer, MD (Research profile | Find a Doctor profile)

Purpose: To evaluate the safety of long-term use of FDA-approved Optimizer Smart cardiac contractility modulation (CCM) therapy and the effects on quality of life, heart failure symptoms and heart function.

Major inclusion criteria:

• Left ventricle ejection fraction between 25-45%
• NYHA class III symptoms

Major exclusion criteria:

• CRT (Cardiac Resynchronization Therapy) or having an indication for it
• Receiving IV Inotropes (Inotropes are medicines that change the force of the heart’s contractions)

Learn more: View this trial on clinicaltrials.gov.

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REST

Principal investigator: John Boehmer, MD (Research profile | Find a Doctor profile)

Purpose: Evaluate the effects of the remedē system on heart failure regardless of ejection fraction. A history of heart failure is NOT required.

Major inclusion criteria:

• Moderate to severe central sleep apnea with an AHI (Apnea-Hypopnea index) of more than 15 events per hour. AHI is the combined average number of apnea and hypopnea events that occur per hour of sleep.
• 18 years old and older

Major exclusion criteria:

• Not involved in another investigational study

Learn more: View this trial on clinicaltrials.gov.

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REBIRTH

Principal investigator: John Boehmer, MD (Research profile | Find a Doctor profile)

Purpose: To look at the use of bromocriptine and its impact on myocardial recovery in newly diagnosed peripartum cardiomyopathy within five months postpartum

Major inclusion criteria:

• New diagnosis of cardiomyopathy within five months
• Left ventricle ejection fraction less than or equal to 35%

Major exclusion criteria:

• Previous diagnosis of cardiomyopathy, valvular disease or complex congenital disease
• Currently pregnant
• Cannot be actively breastfeeding

Learn more: View this trial on clinicaltrials.gov.

Hermes

Principal investigator: John Boehmer, MD (Research profile | Find a Doctor profile)

Purpose: Looking at the effects of ziltivekimab vs. placebo on morbidity and mortality in patients with heart failure with mildly reduced or preserved ejection fraction and systemic inflammation.

Major Inclusion Criteria:

• Serum hs-CRP greater than or equal to 2 mg/L at screening
• At least one of the following:
  • NT-proBNP greater than or equal to 300 pg/mL at screening (Visit 1) for patients without ongoing atrial fibrillation/flutter. If ongoing atrial fibrillation/flutter at screening (visit 1), NT-proBNP must be greater than or equal to 600 pg/mL.
  • HF (heart failure) hospitalization or urgent/unplanned visit with a primary diagnosis of decompensated heart failure which required intravenous loop diuretic treatment, within the last 9 months prior to screening (visit 1) in combination with NT-proBNP greater than or equal to 200 pg/mL at screening (Visit 1) for patients without ongoing atrial fibrillation/flutter. If ongoing atrial fibrillation/flutter at screening (visit 1), NT-proBNP must be greater than or equal to 600 pg/mL.
• Diagnosis of heart failure (NYHA Class II-IV)
• LVEF greater than 40% documented by echocardiography within 12 months prior to or at screening (visit 1). The LVEF (left ventricular ejection fraction) must be documented in medical records and the most recent measurement must be used to determine eligibility with no interim event signalling potential deterioration in ejection fraction (e.g., MI (myocardial infarction) or HF hospitalisation).
• Structural heart disease and/or functional heart disease documented by echocardiography within 12 months prior to or at screening (visit 1) showing at least one of the following:
  • LA (left atria) volume index greater than 34 mL/m2
  • LA diameter greater than or equal to 3.8 cm
  • LA length greater than or equal to 5.0 cm
  • LA area greater than or equal to 20 cm2
  • LA volume greater than or equal to 55 mL
  • Intraventricular septal thickness greater than or equal to 1.1 cm
  • Posterior wall thickness greater than or equal to 1.1 cm
  • LV (left ventricle) mass index greater than or equal to 115 g/m2 in men or greater than or equal to 95 g/m2 in women
  • E/e’ (mean septal and lateral) greater than or equal to 10
  • e’ (mean septal and lateral) greater than 9 cm/s

Major exclusion criteria:

• Unstable heart failure therapy within 14 days of screening
• Active hepatitis C
• Myocardial infarction, stroke, unstable angina pectoris, transient ischaemic attack, or heart failure hospitalisation within 30 days prior to screening (visit 1)
• Systolic blood pressure greater than or equal to 180 mmHg at screening (visit 1)
• Heart rate above 110 or below 40 beats per minute as evaluated on the ECG performed at screening (visit 1)
• Planned coronary, carotid or peripheral artery revascularisation known during the screening period (visit 1)
• Planned cardiac device or atrial flutter/atrial fibrillation ablation procedure known during the screening period (visit 1)
• Major cardiac surgical, non-cardiac surgical, or major endoscopic procedure (thoracoscopic or laparoscopic) within the past 60 days prior to randomisation (visit 2) or any major surgical procedure planned at the time of randomisation (visit 2)
• Left Ventricular Assist Device (LVAD) implantation or heart transplantation
• Heart failure due to infiltrative cardiomyopathy (e.g., sarcoid, amyloid), arrhythmogenic right ventricular cardiomyopathy, Takutsubo cardiomyopathy, genetic hypertrophic cardiomyopathy or obstructive cardiomyopathy, active myocarditis, constrictive pericarditis, cardiac tamponade, uncorrected more than moderate primary valve disease.
• Primary pulmonary hypertension, chronic pulmonary embolism, severe pulmonary disease including COPD
• Diagnosis of human immunodeficiency virus (HIV) and not receiving a stable antiretroviral regimen, at the discretion of the investigator at screening (visit 1)
• History or evidence of untreated latent tuberculosis (TB) such as (but not limited to):
  • History of a positive TB test or chest X-ray compatible with latent TB; and TB treatment initiated less than 28 days prior to randomization (visit 2)
  • Confirmed positive for latent TB at screening (visit 1) (see Section 8.2.7 for details) and TB treatment initiated less than 28 days prior to randomization (visit 2)

Learn more: View this trial on clinicaltrials.gov.

General cardiology and interventional cardiology

SOS-AMI

Principal investigator: Ian Gilchrist, MD (Research profile | Find a Doctor profile)

Purpose: To evaluate the efficacy and safety of self-administered subQ (subcutaneous) selatogrel for prevention of all-cause death and treatment of acute MI (Myocardial Infarction) in subjects with recent history of acute MI (Myocardial Infarction). Selotogrel is a P2Y12 receptor antagonist which provides prompt and potent platelet inhibition.

Major inclusion criteria:

• Individual whom has had an MI (Myocardial Infarction) within the past 4 weeks
• Presence of either a second MI (Myocardial Infarction) within one year or having at least two of the following risk factors: DM (Diabetes Mellitus), CKD (Chronic Kidney Disease), multivessel CAD (Coronary Artery Disease), PAD (Peripheral Arterial Disease), 65 years old or older, or being an active daily smoker
• Discharged with confirmed type 1 AMI (Acute Myocardial Infarction)

Major exclusion criteria:

• Chronic anemia with hemoglobin less than 10
• Increased risk of serious bleeding such as having a history of GI (Gastrointestinal) bleed, triple antithrombotic, intracranial bleed
• Platelet count less than 100,000

Learn more: View this trial on clinicaltrials.gov.

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SELUTION SLR

Principal investigator: Ian Gilchrist, MD (Research profile | Find a Doctor profile)

Purpose: To demonstrate the safety and efficacy of the SELUTION SLR 014 DEB for treatment of bare-metal or drug-eluting in-stent restenosis (ISR).

Major inclusion criteria:

• Patient with documented angina or positive functional testing, unstable angina or stabilized non-ST-elevation myocardial infarction (NSTEMI) with an indication for percutaneous coronary intervention (PCI) and planned intervention.
• Patient meeting imaging inclusion criteria such as target lesion is within a previously placed bare-metal or drug eluting stent

Major exclusion criteria:

• ST-evaluation myocardial infarction (STEMI) with 30 days.
• Patient meeting imaging exclusion criteria such as target lesion is totally occluded or involves an unprotected left main artery

Learn more: View this trial on clinicaltrials.gov.

Vascular surgery

Lutonix AV PAS

Principal investigator: Faisal Aziz, MD (Research profile | Find a Doctor profile)

Purpose: Demonstrate safety and assess the use and outcomes of the Lutonix drug coated balloon for treatment of dysfunctional arteriovenous fistula located in the arm.

Major inclusion criteria:

• Target lesion must be a mature AV (Arteriovenous) fistula located in the arm, presenting with any clinical, physiological or hemodynamic abnormalities
• Successful pre-dilation of the target lesion with an uncoated percutaneous transluminal angioplasty (PTA) balloon

Major exclusion criteria:

• Patient participating in another investigational study

Learn more: View this trial on clinicaltrials.gov.

PROMISE III Study

Primary Investigator: Tarik Ali, MD (Research profile | Find a Doctor profile)

Purpose: Purpose: The objective of this study is to provide additional information on the LimFlow System for creating an arteriovenous (AV) connection in the below the knee (BTK) vascular system using an endovascular, minimally invasive approach to arterialize the pedal veins for the treatment of chronic limb-threatening ischemia in subjects ineligible for conventional endovascular or surgical limb salvage procedures.

Major inclusion criteria:

• Chronic limb-threatening ischemia diagnosed via angiogram or hemodynamic study and
• Rutherford Classification 5, ischemic ulceration or Rutherford Classification 6, ischemic gangrene.
• Limb salvage is not possible using conventional distal bypass surgery or endovascular therapy

Major exclusion criteria:

• Hepatic insufficiency, immunodeficiency disorder, active infection, lower extremity vascular disease
• Prior peripheral arterial bypass
• Tissue in target foot is not viable

Learn more: View this trial on clinicaltrials.gov.

Cardiothoracic surgery

COMPETENCE

Principal investigator: Behzad Soleimani, MD (Research profile | Find a Doctor profile)

Purpose: To evaluate the safety and performance of the EVAHEART 2 LVAS (Left Ventricular Assist System) in patients with advanced heart failure whom require implantation of a durable Left Ventricular Assist Device.

Major inclusion criteria:

• Left ventricle ejection fraction less than 30%
• Inotrope Dependent or having severe HF (Heart Failure) in which one is dependent upon an IABP (Intra-Aortic Balloon Pump) for at least seven days, or an IMPELLA heart pump device for at least three days. The IABP and IMPELLA devices are temporary mechanical heart assist devices that help the heart to pump more blood.
• NYHA class III with dyspnea (difficult or labored breathing) upon mild physical activity or NYHA Class IV

Major exclusion criteria:

• Planned BiVad support
• Platelet count less than 100,000
• History of any organ transplant

Learn more: View this trial on clinicaltrials.gov.

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Guardian Registry

Principal investigator: Balakrishnan Mahesh, MD (Research profile | Find a Doctor profile)

Purpose: Post market, observational registry of adult and pediatric heart transplant recipient patients whose donor heart was preserved and transported with SherpaPak Cardiac Transport System.

Major inclusion criteria:

• Donor and donor hearts matched to the prospective recipient based upon institutional medical practice
• Recipient: registered male or female primary heart transplant candidates

Major exclusion criteria:

• Donor and donor hearts that do not meet institutional clinical requirements for transplantation
• Recipient: when safe connection with aorta cannot be made. Patients who are incarcerated or have had a previous transplant.

Learn more: View this trial on clinicaltrials.gov.

Structural heart disease trials

CorCinch-HF 5019

Principal investigator: John Boehmer, MD (Research profile | Find a Doctor profile)

Purpose: To evaluate the safety and efficacy of the AccuCinch Ventricular Restoration System in patients with heart failure with reduced ejection fraction (HFrEF)

Major inclusion criteria:

• Left ventricle ejection fraction greater than or equal
• NYHA Class III, Ambulatory Class IV or Class II with a heart failure hospitalization within the past 12 months

Major exclusion criteria:

• Diagnosed with heart failure other than ischemic and non-ischemic (i.e. hypertrophic, amyloid, restrictive etc.)
• Moderate to severe valvular abnormalities
• Renal insufficiency with estimated Glomerular Filtration Rate (eGFR), which is a measurement of how much blood the kidneys filter each minute < 25

Learn more: View this trial on clinicaltrials.gov.

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PFO (Patent Foramen Ovale) Occluder

Principal investigator: Mark Kozak, MD (Research profile | Find a Doctor profile)

Purpose: Demonstrate safety and effectiveness of the AMPLATZER PFO (Patent Foramen Ovale) Occluder in patients with a PFO (Patent Foramen Ovale) who have had a cryptogenic stroke. Cryptogenic stroke is defined as a cerebral ischemia of obscure or unknown origin.

Major inclusion criteria:

• Patient with PFO (Patent Foramen Ovale) and ischemic stroke within previous 547 days and have undergone investigation by neurologist to exclude other known causes of ischemic stroke. Ischemic stroke occurs when the blood supply to part of the brain is interrupted or reduced, preventing brain tissue from getting oxygen and nutrients.
• Age between 18-60

Major exclusion criteria:

• Atrial fibrillation or A-flutter
• Left ventricle ejection fraction less than 35%

Learn more: View this trial on clinicaltrials.gov.

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Clasp II TR (TR stands for Tricuspid Regurgitation)

Principal investigator: Mark Kozak, MD (Research profile | Find a Doctor profile)

Purpose: To evaluate the safety and effectiveness of transcatheter tricuspid valve repair with the Edwards system and optimal medical therapy compared to optimal medical therapy alone.

Major inclusion criteria:

• NYHA Class II-IVa or heart failure hospitalization within previous 12 months
• Functional or degenerative TR (Tricuspid Regurgitation) graded as severe or greater

Major exclusion criteria:

• Left ventricle ejection fraction less than or equal to 25%
• Primary non-degenerative tricuspid disease (i.e. Endocarditis, rheumatic, carcinoid, etc.)
• Infiltrative cardiomyopathy or valvulopathy or significant congenital heart disease

Learn more: View this trial on clinicaltrials.gov.

Electrophysiology (heart rhythm)

No open studies at this time.

Upcoming available studies

Cardiology

ARTEMIS
Principal Investigator: Michael Farbaniec, MD (Research profile | Find a Doctor profile)
Purpose: The primary purpose of this study is to evaluate the effects of ziltivekimab compared to placebo in reducing major adverse cardiovascular events in adult patients with acute myocardial infarction. Ziltivekimab, a human monoclonal antibody, has been previously shown to reduce inflammation in patients with CKD and may similarly work to reduce risk of major adverse cardiovascular events.
Learn more: View this trial at clinicaltrials.gov.

Dal-GenE-2
Principal investigator: Ian Gilchrist, MD (Research profile | Find a Doctor profile)
Purpose: Research has consistently shown that a decrease in HDL-C levels are associated with an increased risk of developing coronary heart disease. Dalcetrapib is a compound that increases levels of HDL-C through modulation of plasma CETP activity. The primary objective of this trial is to evaluate the potential of dalcetrapib to safely reduce the incidence of fatal and non-fatal myocardial infarction in patients with documented recent acute coronary syndrome and the AA genotype.
Learn more: View this trial at clinicaltrials.gov.

Heart Failure/Heart Transplant

PROACTIVE-2
Principal investigator: John Boehmer, MD (Research profile | Find a Doctor profile)
Purpose: The Cordella PA Sensor System, in conjunction with Cordella Heart Failure System, will be used to measure, record, and transmit pulmonary artery pressure data from NYHA Class II-III heart failure patients at home to clinicians for assessment. The overall purpose of this study is to reduce heart failure hospitalizations by enabling clinical decision making and clinician-directed self-management prior to the development of symptoms.
Learn more: View this trial at clinicaltrials.gov.

Contacts

For more information about heart and vascular clinical trial opportunities at Penn State Health Holy Spirit Medical Center-Cardiology:

Contact: Nicole Grassmyer BSN, RN, CV-BC
Phone: 717-724-6304
Email: ngrassmyer@pennstatehealth.psu.edu
Address: 875 Poplar Church Rd Suite 400
Camp Hill, PA 17011

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For more information about heart and vascular clinical trial opportunities at Penn State Health Medical Group-Berks Cardiology:.

Contact: Emese Futchko, RN, MSN, CCRC
Phone: 610-685-8500 ext. 271
Email: efutchko@pennstatehealth.psu.edu
Address: 2605 Keiser Blvd.
Wyomissing, PA 19610

Penn State Health Medical Group – Berks Cardiology

CREST-2

Principal investigator: Guy N. Piegari, MD (Find a Doctor profile)

Contact: Emese Futchko, RN, MSN, CCRC – 610-685-8500, ext. 271 or efutchko@pennstatehealth.psu.edu

Purpose: Carotid Revascularization and Medical Management for Asymptomatic Carotid Stenosis Trial (Crest-2) Protocol

Major inclusion criteria:

• Carotid stenosis defined as: Stenosis greater than or equal to 70% by catheter angiography (NASCET Criteria); or by DUS with greater than or equal to 70% stenosis defined by a peak systolic velocity of at least 230 cm/s
  • Plus at least one of the following:
    • an end diastolic velocity greater than or equal to 100 cm/s
    • internal carotid/common carotid artery peak systolic velocity ratio greater than or equal to4.0
  • CTA (Computed Tomography Angiography)with greater than or equal to 70% stenosis, or d) MRA(magnetic resonance angiography) with greater than or equal to 70% stenosis.
• No medical history of stroke or TIA (transient ischemia attack) ipsilateral to the stenosis within 180 days of randomization.
• Life-long asymptomatic patients.

Major exclusion criteria:

• GI (gastrointestinal) hemorrhage within one month of enrollment
• Severe dementia
• Chronic atrial fibtillation
• Left ventricle ejection fraction less than 30% within six months of enrollment
• Malignant cancer

C2LOE

Principal investigator: Guy N. Piegari, MD (Find a Doctor profile)

Contact: Emese Futchko, RN, MSN, CCRC – 610-685-8500, ext. 271 or efutchko@pennstatehealth.psu.edu

Purpose: The primary aim of this study is to compare the post-procedure treatment differences in stroke risk between those randomized to revascularization and intensive medical management (IMM) and those randomized to IMM alone.

Major inclusion criteria:

• Currently active or graduated participants in the CREST-2 randomized trial
• Able to provide written informed consent by self
• Fluent in English

Major exclusion criteria:

• Unable to provide written informed consent
• Inability to follow study procedures

SOS-AMI

Principal investigator: Ronald J. Polinsky Jr., MD (View Find a Doctor profile)

Contact: Emese Futchko, RN, MSN, CCRC – 610-685-8500, ext. 271 or efutchko@pennstatehealth.psu.edu

Purpose: The primary objective of the study is to assess the clinical efficacy of selatogrel when self-administered upon occurrence of symptoms suggestive of an acute myocardial infarction (AMI) in subjects at risk of having a recurrent AMI (acute myocardial infarction).

Major inclusion criteria:

• Confirmed diagnosis of symptomatic type 1 AMI [STEMI (ST-elevation myocardial infaction)or NSTEMI (non-ST elevation myocardial infaction)], no longer than four weeks prior to randomization.
• Diagnosis of multivessel coronary artery disease defined as greater than or equal to 50% stenosis on two or more coronary artery territories or on the left main artery during a prior cardiac catheterization or cardiac catheterization during the qualifying AMI event and presence of at least two of the following risk factors:
  • Second prior AMI
  • Diabetes mellitus defined by ongoing glucose lowering treatment
  • Chronic kidney disease with estimated glomerular filtration rate less than 60 mL/min/1.73 m2
  • PAD (peripheral arterial disease) defined as any of the following at any time prior to randomization:
    • Ankle/brachial index less than 0.85
    • Amputation, peripheral bypass, or peripheral angioplasty of the extremities secondary to ischemia.
  • Absence of, or unsuccessful coronary revascularization of the qualifying AMI referred to in inclusion criterion 3

Major exclusion criteria:

• Intracranial bleed
• Uncorrected intracranial vascular abnormality
• GI bleed within one year of screening
• Oral triple antithrombotic therapy
• Dialysis

C2R registry

Principal investigator: Guy N. Piegari, MD (Find a Doctor profile)

Contact: Emese Futchko, RN, MSN, CCRC – 610-685-8500, ext. 271 or efutchko@pennstatehealth.psu.edu

Purpose: Promote rapid initiation and completion of enrollment in the CREST-2 trial. Ensure that CAS (carotid artery stenting) is performed by adequately experienced operators within CREST-2 and C2R Closely monitor clinical outcomes of C2R patients. Prevent inappropriate use of CAS outside of C2R

Major inclusion criteria:

• Asymptomatic patients
  • Age: between 18 and 80 and any one of the following:
    • Greater than or equal to 70% stenosis, standard surgical risk for CEA (carotid endarterectomy)
    • Greater than or equal to 70% stenosis, high anatomic risk for CEA
    • Greater than or equal to 70% stenosis, high physiologic risk for CEA
  • Symptomatic patients
    • Symptomatic patients are defined by the following characteristics:
      • Ipsilateral carotid Transient Ischemic Attack (TIA), with neurologic symptoms persisting less than 24 hours;
      • Ipsilateral non-disabling stroke: Modified Rankin Scale (mRS) less than or equal to 3
      • Ipsilateral transient monocular blindness: amaurosis fugax
    • Age: between 18 and 80 and any one of the following:
      • Greater than or equal to50% stenosis, standard surgical risk for CEA
      • 50% to 69% stenosis, high anatomic risk for CEA
      • 50% to 69% stenosis, high physiologic risk
      • Greater than or equal to70% stenosis, high anatomic and/or physiologic risk for CEA – currently covered by Medicare, but sites are strongly encouraged to voluntarily include these patients in C2R
      • Greater than or equal to 70% stenosis, post-CEA and –CAS – currently covered by Medicare, but sites are strongly encouraged to voluntarily include these patients in C2R
      • Greater than or equal to 70% stenosis, post-irradiation – currently covered by Medicare, but sites are strongly encouraged to voluntarily include these patients in C2R

Major exclusion criteria:

• NYHA Class IV CHF (congestive heart failure)
• COPD (chronic obstructive pulmonary disease) on chronic continuous oxygen therapy
• Severe (Childs Class D) liver failure
• Cancer with metastatic spread and/or undergoing active chemotherapeutic treatment
• Any dementia considered greater than “mild”

Hermes

Principal investigator: David Zisa, MD (Find a Doctor profile)

Purpose: Looking at the effects of ziltivekimab vs. placebo on morbidity and mortality in patients with heart failure with mildly reduced or preserved ejection fraction and systemic inflammation.

Contact: Emese Futchko, RN, MSN, CCRC – 610-685-8500, ext. 271 or efutchko@pennstatehealth.psu.edu

Major Inclusion Criteria:

• Serum hs-CRP greater than or equal to 2 mg/L at screening
• At least one of the following:
  • NT-proBNP greater than or equal to 300 pg/mL at screening (Visit 1) for patients without ongoing atrial fibrillation/flutter. If ongoing atrial fibrillation/flutter at screening (visit 1), NT-proBNP must be greater than or equal to 600 pg/mL.
  • HF (heart failure) hospitalization or urgent/unplanned visit with a primary diagnosis of decompensated heart failure which required intravenous loop diuretic treatment, within the last 9 months prior to screening (visit 1) in combination with NT-proBNP greater than or equal to 200 pg/mL at screening (Visit 1) for patients without ongoing atrial fibrillation/flutter. If ongoing atrial fibrillation/flutter at screening (visit 1), NT-proBNP must be greater than or equal to 600 pg/mL.
• Diagnosis of heart failure (NYHA Class II-IV)
• LVEF greater than 40% documented by echocardiography within 12 months prior to or at screening (visit 1). The LVEF (left ventricular ejection fraction) must be documented in medical records and the most recent measurement must be used to determine eligibility with no interim event signalling potential deterioration in ejection fraction (e.g., MI (myocardial infarction) or HF hospitalisation).
• Structural heart disease and/or functional heart disease documented by echocardiography within 12 months prior to or at screening (visit 1) showing at least one of the following:
  • LA (left atria) volume index greater than 34 mL/m2
  • LA diameter greater than or equal to 3.8 cm
  • LA length greater than or equal to 5.0 cm
  • LA area greater than or equal to 20 cm2
  • LA volume greater than or equal to 55 mL
  • Intraventricular septal thickness greater than or equal to 1.1 cm
  • Posterior wall thickness greater than or equal to 1.1 cm
  • LV (left ventricle) mass index greater than or equal to 115 g/m2 in men or greater than or equal to 95 g/m2 in women
  • E/e’ (mean septal and lateral) greater than or equal to 10
  • e’ (mean septal and lateral) greater than 9 cm/s

Major exclusion criteria:

• Unstable heart failure therapy within 14 days of screening
• Active hepatitis C
• Myocardial infarction, stroke, unstable angina pectoris, transient ischaemic attack, or heart failure hospitalisation within 30 days prior to screening (visit 1)
• Systolic blood pressure greater than or equal to 180 mmHg at screening (visit 1)
• Heart rate above 110 or below 40 beats per minute as evaluated on the ECG performed at screening (visit 1)
• Planned coronary, carotid or peripheral artery revascularisation known during the screening period (visit 1)
• Planned cardiac device or atrial flutter/atrial fibrillation ablation procedure known during the screening period (visit 1)
• Major cardiac surgical, non-cardiac surgical, or major endoscopic procedure (thoracoscopic or laparoscopic) within the past 60 days prior to randomisation (visit 2) or any major surgical procedure planned at the time of randomisation (visit 2)
• Left Ventricular Assist Device (LVAD) implantation or heart transplantation
• Heart failure due to infiltrative cardiomyopathy (e.g., sarcoid, amyloid), arrhythmogenic right ventricular cardiomyopathy, Takutsubo cardiomyopathy, genetic hypertrophic cardiomyopathy or obstructive cardiomyopathy, active myocarditis, constrictive pericarditis, cardiac tamponade, uncorrected more than moderate primary valve disease.
• Primary pulmonary hypertension, chronic pulmonary embolism, severe pulmonary disease including COPD
• Diagnosis of human immunodeficiency virus (HIV) and not receiving a stable antiretroviral regimen, at the discretion of the investigator at screening (visit 1)
• History or evidence of untreated latent tuberculosis (TB) such as (but not limited to):
  • History of a positive TB test or chest X-ray compatible with latent TB; and TB treatment initiated less than 28 days prior to randomization (visit 2)
  • Confirmed positive for latent TB at screening (visit 1) (see Section 8.2.7 for details) and TB treatment initiated less than 28 days prior to randomization (visit 2)

Learn more: View this trial on clinicaltrials.gov.

REACT-AF

Principal investigator: Ronald J. Polinsky, MD (View Find a Doctor profile)

Contact: Emese Futchko, RN, MSN, CCRC – 610-685-8500, ext. 271; or efutchko@pennstatehealth.psu.edu

Purpose: To assess whether AFSW (Atrial fibrillation sensing smart watch)-guided, time-delimited DOAC (direct continuous oral anticoagulation) therapy is non-inferior to continuous DOAC therapy for a composite endpoint that includes: (1) Ischemic stroke; (2) Systemic embolism; (3) All-cause mortality.

Major Inclusion Criteria:

• 22-85 years of age.
• English-speaking participants
• Documented history of symptomatic or asymptomatic paroxysmal or persistent AF. The duration of AF must have been > 30 seconds as documented by an external monitor or present on 12-lead ECG.
• CHA2DS2-VASC score of 1-4 without prior stroke or TIA**
• The participant is on a DOAC at the time of screening.
• Willing and able to comply with the protocol, including:
  • Possession of a smartwatch-compatible smartphone (iPhone that supports the latest shipping iOS) with a cellular service plan
  • Be willing to wear the smartwatch for the suggested minimum of 14 hours a day
  • Expected to be within cellular service range at least 80% of the time
• Willing and able to discontinue DOAC

Major exclusion criteria:

• Valvular or permanent atrial fibrillation.
• Current treatment with warfarin and unwilling or unable to take a DOAC.
• The participant is a woman who is pregnant, nursing, or of child-bearing potential and is not on birth control.
• The participant is being treated with chronic aspirin, another anti-platelet agent, or chronic NSAIDS outside of current medical guidelines (e.g., primary stroke prevention in patients with atrial fibrillation, primary prevention of cardiovascular events, pain relief, fever, gout) and is unwilling or unable to discontinue use for the study duration.
• Existing cardiac rhythm device or indication for a permanent pacemaker, ICD or CRT device or planned insertable cardiac monitor.
• Any documented single AF episode lasting ≥ 1 hour on screening external cardiac monitor of > 6 days duration.
• Mechanical prosthetic valve(s) or severe valve disease.
• Hypertrophic cardiomyopathy.
• Participant needs DOAC for reasons other than preventing stroke or arterial embolism resulting from AF (i.e., preventing DVT or PE) or needs permanent OAC (i.e., congenital heart defects, prosthetic heart valve).
• Participants deemed high risk for non-cardioembolic stroke (i.e., significant carotid artery disease defined as stenosis > 75%) based on the investigator’s discretion.
• The participant is enrolled, has participated within the last 30 days, or is planning to participate in a concurrent drug and/or device study during the course of this clinical trial. Co-enrollment in concurrent trials is only allowed with documented pre-approval from the study manager; there is no concern that co-enrollment could confound the results of this trial.
• The participant has a tattoo, birthmark, or surgical scar over the dorsal wrist area on the ipsilateral side that the AFSW may be worn.
• The participant has a tremor on their ipsilateral side that the AFSW may be worn.
• Any concomitant condition that, in the investigator’s opinion, would not allow safe participation in the study (e.g., drug addiction, alcohol abuse).
• Known hypersensitivity or contraindication to direct oral anticoagulants.
• Documented prior stroke (ischemic or hemorrhagic) or transient ischemic attack.
• Reversible causes of AF (e.g., cardiac surgery, pulmonary embolism, untreated hyperthyroidism). AF ablation does not constitute reversible AF.
• > 5% burden premature atrial or ventricular depolarizations on any given calendar day on pre-enrollment cardiac monitoring.
• History of atrial flutter that has not been treated with ablation (participants in atrial flutter and have been ablated are eligible for enrollment).
• Stage 4 or 5 chronic kidney disease.
• Conditions associated with an increased risk of bleeding:
  • Major surgery in the previous month
  • Planned surgery or intervention in the next three months.
  • History of intracranial, intraocular, spinal, retroperitoneal, or atraumatic intraarticular bleeding
  • Gastrointestinal hemorrhage within the past year unless the cause has been permanently eliminated (e.g., by surgery)
  • Symptomatic or endoscopically documented gastroduodenal ulcer disease in the previous 30 days
  • Hemorrhagic disorder or bleeding diathesis
  • Need for anticoagulant treatment for disorders other than AF
  • Required use of non-aspirin antiplatelet agents (i.e., Plavix) at time of enrollment
  • Uncontrolled hypertension (SBP >180 mmHg and/or DBP >100 mmHg

Penn State Health Holy Spirit Medical Center

Hermes

Principal investigator: Andreas Wali, MD (Find a Doctor profile)

Contact: Nicole Grassmyer BSN, RN, CV-BC – 717-724-6304 or ngrassmyer@pennstatehealth.psu.edu

Purpose: Looking at the effects of ziltivekimab vs. placebo on morbidity and mortality in patients with heart failure with mildly reduced or preserved ejection fraction and systemic inflammation.

Major Inclusion Criteria:

• Serum hs-CRP greater than or equal to 2 mg/L at screening
• At least one of the following:
  • NT-proBNP greater than or equal to 300 pg/mL at screening (Visit 1) for patients without ongoing atrial fibrillation/flutter. If ongoing atrial fibrillation/flutter at screening (visit 1), NT-proBNP must be greater than or equal to 600 pg/mL.
  • HF (heart failure) hospitalization or urgent/unplanned visit with a primary diagnosis of decompensated heart failure which required intravenous loop diuretic treatment, within the last 9 months prior to screening (visit 1) in combination with NT-proBNP greater than or equal to 200 pg/mL at screening (Visit 1) for patients without ongoing atrial fibrillation/flutter. If ongoing atrial fibrillation/flutter at screening (visit 1), NT-proBNP must be greater than or equal to 600 pg/mL.
• Diagnosis of heart failure (NYHA Class II-IV)
• LVEF greater than 40% documented by echocardiography within 12 months prior to or at screening (visit 1). The LVEF (left ventricular ejection fraction) must be documented in medical records and the most recent measurement must be used to determine eligibility with no interim event signalling potential deterioration in ejection fraction (e.g., MI (myocardial infarction) or HF hospitalisation).
• Structural heart disease and/or functional heart disease documented by echocardiography within 12 months prior to or at screening (visit 1) showing at least one of the following:
  • LA (left atria) volume index greater than 34 mL/m2
  • LA diameter greater than or equal to 3.8 cm
  • LA length greater than or equal to 5.0 cm
  • LA area greater than or equal to 20 cm2
  • LA volume greater than or equal to 55 mL
  • Intraventricular septal thickness greater than or equal to 1.1 cm
  • Posterior wall thickness greater than or equal to 1.1 cm
  • LV (left ventricle) mass index greater than or equal to 115 g/m2 in men or greater than or equal to 95 g/m2 in women
  • E/e’ (mean septal and lateral) greater than or equal to 10
  • e’ (mean septal and lateral) greater than 9 cm/s

Major exclusion criteria:

• Unstable heart failure therapy within 14 days of screening
• Active hepatitis C
• Myocardial infarction, stroke, unstable angina pectoris, transient ischaemic attack, or heart failure hospitalisation within 30 days prior to screening (visit 1)
• Systolic blood pressure greater than or equal to 180 mmHg at screening (visit 1)
• Heart rate above 110 or below 40 beats per minute as evaluated on the ECG performed at screening (visit 1)
• Planned coronary, carotid or peripheral artery revascularisation known during the screening period (visit 1)
• Planned cardiac device or atrial flutter/atrial fibrillation ablation procedure known during the screening period (visit 1)
• Major cardiac surgical, non-cardiac surgical, or major endoscopic procedure (thoracoscopic or laparoscopic) within the past 60 days prior to randomisation (visit 2) or any major surgical procedure planned at the time of randomisation (visit 2)
• Left Ventricular Assist Device (LVAD) implantation or heart transplantation
• Heart failure due to infiltrative cardiomyopathy (e.g., sarcoid, amyloid), arrhythmogenic right ventricular cardiomyopathy, Takutsubo cardiomyopathy, genetic hypertrophic cardiomyopathy or obstructive cardiomyopathy, active myocarditis, constrictive pericarditis, cardiac tamponade, uncorrected more than moderate primary valve disease.
• Primary pulmonary hypertension, chronic pulmonary embolism, severe pulmonary disease including COPD
• Diagnosis of human immunodeficiency virus (HIV) and not receiving a stable antiretroviral regimen, at the discretion of the investigator at screening (visit 1)
• History or evidence of untreated latent tuberculosis (TB) such as (but not limited to):
  • History of a positive TB test or chest X-ray compatible with latent TB; and TB treatment initiated less than 28 days prior to randomization (visit 2)
  • Confirmed positive for latent TB at screening (visit 1) (see Section 8.2.7 for details) and TB treatment initiated less than 28 days prior to randomization (visit 2)

Learn more: View this trial on clinicaltrials.gov.