Prospective Evaluation of Elastic Restraint to LESSen the Effects of Heart Failure (PEERLESS-HF) Trial

NCT ID: NCT00382863

Last Updated: 2012-07-13

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 220 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-10-31
• Study Completion Date: 2012-05-31

Brief Summary

The purpose of this study is to determine if patients in the HeartNet Ventricular Support System with optimal medical and device therapy arm (Treatment group) show statistically significant improvement compared to patients in the optimal medical and device therapy alone arm (Control group) after 6 months of follow-up.

Detailed Description

In the United States alone, more than five million people suffer from heart failure (CHF) and an estimated 400,000 to 700,000 new cases are diagnosed each year. Caused by a variety of cardiac conditions, systolic heart failire (HF) is the end-stage of heart disease where the heart is failing as a pump. Once diagnosed with the disease, less than 50% of the patients live for five years, and less than 25% survive for more than ten years. The number of deaths in the United States from this condition has more than doubled since 1979, averaging more than 250,000 annually.

Paracor Medical, Inc. has developed an elastic prosthetic wrap that is designed to apply a gentle mechanical support to the failing heart. The Implant is a compliant elastic structure that is designed to conform to the epicardial surface of the right and left ventricles. It supports the heart throughout the cardiac cycle and was designed to offload the ventricles and reduce wall stress.

The objective of this clinical trial is to evaluate the safety and efficacy of the HeartNet Ventricular Support System with optimal medical and device therapy (Treatment group) when compared to optimal medical and device therapy (i.e., medications, cardiac resynchronisation therapy, pacemaker) alone (Control group) as treatments for patients with heart failure.

Efficacy of the HeartNet Ventricular Support System in the Treatment group compared to the optimal medical and device therapy Control group will be evaluated based upon cardiopulmonary tests (Peak VO2), six (6) minute walk distance and quality of life assessment, as measured by the Minnesota Living with Heart Failure (MLWHF) questionnaire.

Safety of the HeartNet Ventricular Support System in the Treatment group compared to the Control group will be evaluated based on the all-cause mortality rate.

Paracor Medical intends to submit data obtained in this clinical trial to support a Pre-Market Approval Application to the United States Food and Drug Administration.

Conditions

Heart Failure

Keywords

heart failure; cardiac support; Paracor; HeartNet; PEERLESS-HF

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Treatment

HeartNet and Optimal Medical/Device Therapy (e.g., medications and cardiac resynchronisation therapy)

Group Type: EXPERIMENTAL

HeartNet Ventricular Support System

Intervention Type: DEVICE

The HeartNet Implant is placed on the epicardial surface of the heart surrounding both the left and right ventricles.

Control

Optimal Medical/Device Therapy alone (e.g., medications and/or cardiac resynchronisation therapy) (Note: For the purpose of the PEERLESS-HF study, optimal medical therapy is defined as the use of angiotensin converting enzyme (ACE) inhibitors and Beta blockers in the highest tolerable doses for three months prior to study enrollment, and Optimal device therapy is defined as cardiac resynchronization therapy (CRT) or cardiac resynchronization therapy-defibrillator (CRT-D) for at least three months prior to study enrollment, when indicated.)

Group Type: ACTIVE_COMPARATOR

Optimal Medical/Device Therapy

Intervention Type: DRUG

Optimal Medical/Device Therapy - For the purpose of the PEERLESS-HF study, optimal medical therapy is defined as the use of ACE inhibitors and Beta blockers in the highest tolerable doses for three months prior to study enrollment, and Optimal device therapy is defined as CRT or CRT-D for at least three months prior to study enrollment, when indicated.

Interventions

HeartNet Ventricular Support System

The HeartNet Implant is placed on the epicardial surface of the heart surrounding both the left and right ventricles.

Intervention Type: DEVICE

Optimal Medical/Device Therapy

Optimal Medical/Device Therapy - For the purpose of the PEERLESS-HF study, optimal medical therapy is defined as the use of ACE inhibitors and Beta blockers in the highest tolerable doses for three months prior to study enrollment, and Optimal device therapy is defined as CRT or CRT-D for at least three months prior to study enrollment, when indicated.

Intervention Type: DRUG

Other Intervention Names

cardiac support; heart failure medications

Eligibility Criteria

Inclusion Criteria

1. Symptomatic heart failure at enrollment (American College of Cardiology [ACC]/American Heart Association [AHA] Stage C) due to ischemic or nonischemic dilated cardiomyopathy

2. On stable, evidence-based medical and device therapy for heart failure for 3 months prior to randomization <a> Pharmacological Therapy (as appropriate) <i> angiotensin converting enzyme (ACE) inhibitors or angiotensin II receptor blockers (ARB) for patients with ACE inhibitor intolerance or nitrate/hydralazine at the investigators discretion <ii> beta blockers <iii> diuretics, aldosterone inhibitors <b> Ejection fraction < or = to 35% while maintained on optimal medical therapy <c> Cardiac Resynchronization Therapy (CRT), Cardiac Resynchronization Therapy-Defibrillator (CRT-D) <i> If implanted with a CRT or CRT-D, it must be implanted > or = to 3 months before randomization <ii> If currently eligible or anticipated eligibility with a CRT or CRT-D within 6 months, the patient should not be enrolled in the study

Specific Qualifying Characteristics

1. Six (6) minute walk of 150 - 450m

2. Peak VO2 for males: 10.0-20.0 ml/kg/min; Peak VO2 for females: 9.0-18.0 ml/kg/min

3. Left ventricular end diastolic diameter (LVEDD) <85mm and index <40mm/m2 (LVEDD/BSA)

4. Heart failure duration > or = to 6 months

Exclusion Criteria

Patient History

1. Heart failure due to a reversible condition

2. Hypertrophic obstructive cardiomyopathy (HOCM)

3. Left ventricular assist device (LVAD), intra-aortic balloon pump (IABP) or intravenous inotropes are required or the patient has end stage heart failure despite maintenance on best medical therapy

4. Myxoma

5. Active infection, sepsis, endocarditis, myocarditis or pericarditis

6. Myocardial infarction, stroke, transient ischemic attack, cardiac or other major surgery, or implantable cardioverter defibrillator (ICD) or pacemaker implantation in the 3 months prior to entry

7. Positive pregnancy test for pre-menopausal female

8. Less than 18 years or > or = to 75 years old

9. Hemoglobin level less than 10 gm/dL or creatinine >2.5 mg/dL

10. Uncontrolled medical conditions that increase surgical risk

11. Co-morbid condition that in the investigator's opinion reduces life expectancy to less than 2 years

Surgical or Anatomical Considerations

1. Heart measurement too large or small for Implant sizes

2. Restrictive cardiomyopathy

3. Not a candidate for sternotomy or standard thoracotomy surgical approaches

4. Expected to have adhesions from previous surgical procedures

5. History of constrictive pericarditis

6. Previously placed coronary artery bypass grafts (CABG) or anticipated need for coronary artery bypass grafting

7. Not a candidate for cardiopulmonary bypass

8. Anatomical mitral valve regurgitation of 2+ or greater at the time of enrollment

9. Pulmonary function testing with the following results: Forced expiratory volume (FEV1) <1L or if FEV1 is between 1 and 3L, forced expiratory volume divided by forced vital capacity (FEV1/FVC) <60%

10. Cardiac or thoracic condition that might require operative correction. Cardiac transplantation is not included in this exclusion criterion.

11. Other elective surgical procedure at the time of the index hospitalization or within 30 days, whichever is longer

Other

1. Any other medical condition that, in the judgment of the investigator, makes the patient a poor candidate for this procedure

2. Currently enrolled or has participated in the last 30 days in another therapeutic or interventional clinical study

3. Unwilling/unable to comply with follow-up

4. Unwilling/unable to give signed informed consent

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 74 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Paracor Medical, Inc

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

William T. Abraham, MD

Role: PRINCIPAL_INVESTIGATOR

Chief, Division of Cardiovascular Medicine, The Ohio State University

Locations

University of Alabama Birmingham

Birmingham, Alabama, United States

USC Keck School of Medicine

Los Angeles, California, United States

University of California, San Francisco, Medical Center

San Francisco, California, United States

University of Colorado Health Sciences Center

Aurora, Colorado, United States

Christiana Care Health System

Newark, Delaware, United States

University of Florida

Gainesville, Florida, United States

Emory University

Atlanta, Georgia, United States

Midwest Heart Foundation

Lombard, Illinois, United States

St. Vincent Hospital and Health Services

Indianapolis, Indiana, United States

Genesis Medical Center

Davenport, Iowa, United States

University of Maryland, Division of Cardiology

Baltimore, Maryland, United States

Caritas St. Elizabeth's Medical Center

Boston, Massachusetts, United States

Wayne State University/ Oakwood Hospital

Detroit, Michigan, United States

Minneapolis VA Medical Center

Minneapolis, Minnesota, United States

St. Paul Heart Clinic

Saint Paul, Minnesota, United States

Mid America Heart Institute

Kansas City, Missouri, United States

BryanLGH Heart Improvement Program

Lincoln, Nebraska, United States

Morristown Memorial Hospital

Morristown, New Jersey, United States

University of Rochester Medical Center

Rochester, New York, United States

Montefiore Medical Center

The Bronx, New York, United States

The Lindner Clinical Trial Center

Cincinnati, Ohio, United States

The Ohio State University Medical Center

Columbus, Ohio, United States

Oklahoma Heart Hospital

Oklahoma City, Oklahoma, United States

Penn State Milton S. Hershey Medical Center

Hershey, Pennsylvania, United States

Allegheny General Hospital

Pittsburgh, Pennsylvania, United States

The Stern Cardiovascular Center

Germantown, Tennessee, United States

Tennessee Cardiovascular Research Institute

Nashville, Tennessee, United States

Intermountain Medical Center

Murray, Utah, United States

Inova Heart & Vascular Institute/ Fairfax Hospital

Falls Church, Virginia, United States

University of Calgary

Calgary, Alberta, Canada

St. Paul's Hospital

Vancouver, British Columbia, Canada

St. Boniface General Hospital

Winnipeg, Manitoba, Canada

London Health Sciences Centre

London, Ontario, Canada

Toronto General Hospital

Toronto, Ontario, Canada

McGill University Hospital Centre

Montreal, Quebec, Canada

Countries

United States; Canada

References

Abraham WT, Anand I, Aranda JM Jr, Boehmer J, Costanzo MR, DeMarco T, Holcomb R, Ivanhoe R, Kolber M, Rayburn B. Randomized controlled trial of ventricular elastic support therapy in the treatment of symptomatic heart failure: rationale and design. Am Heart J. 2012 Nov;164(5):638-45. doi: 10.1016/j.ahj.2012.07.015. Epub 2012 Oct 2.

Reference Type: DERIVED

PMID: 23137493 (View on PubMed)

Keteyian SJ, Brawner CA, Ehrman JK, Ivanhoe R, Boehmer JP, Abraham WT; PEERLESS-HF Trial Investigators. Reproducibility of peak oxygen uptake and other cardiopulmonary exercise parameters: implications for clinical trials and clinical practice. Chest. 2010 Oct;138(4):950-5. doi: 10.1378/chest.09-2624. Epub 2010 Jun 3.

Reference Type: DERIVED

PMID: 20522572 (View on PubMed)

Other Identifiers

200

Identifier Type: -

Identifier Source: org_study_id