Heart Failure Clinical Trial

Clinical Trial Finder Heart Failure Trials

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

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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.

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Full 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.

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Eligibility Criteria

Inclusion Criteria:

Symptomatic heart failure at enrollment (American College of Cardiology [ACC]/American Heart Association [AHA] Stage C) due to ischemic or nonischemic dilated cardiomyopathy
On stable, evidence-based medical and device therapy for heart failure for 3 months prior to randomization Pharmacological Therapy (as appropriate) angiotensin converting enzyme (ACE) inhibitors or angiotensin II receptor blockers (ARB) for patients with ACE inhibitor intolerance or nitrate/hydralazine at the investigators discretion beta blockers diuretics, aldosterone inhibitors Ejection fraction < or = to 35% while maintained on optimal medical therapy Cardiac Resynchronization Therapy (CRT), Cardiac Resynchronization Therapy-Defibrillator (CRT-D) If implanted with a CRT or CRT-D, it must be implanted > or = to 3 months before randomization 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

Six (6) minute walk of 150 - 450m
Peak VO2 for males: 10.0-20.0 ml/kg/min; Peak VO2 for females: 9.0-18.0 ml/kg/min
Left ventricular end diastolic diameter (LVEDD) <85mm and index <40mm/m2 (LVEDD/BSA)
Heart failure duration > or = to 6 months

Exclusion Criteria:

Patient History

Heart failure due to a reversible condition
Hypertrophic obstructive cardiomyopathy (HOCM)
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
Myxoma
Active infection, sepsis, endocarditis, myocarditis or pericarditis
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
Positive pregnancy test for pre-menopausal female
Less than 18 years or > or = to 75 years old
Hemoglobin level less than 10 gm/dL or creatinine >2.5 mg/dL
Uncontrolled medical conditions that increase surgical risk
Co-morbid condition that in the investigator's opinion reduces life expectancy to less than 2 years

Surgical or Anatomical Considerations

Heart measurement too large or small for Implant sizes
Restrictive cardiomyopathy
Not a candidate for sternotomy or standard thoracotomy surgical approaches
Expected to have adhesions from previous surgical procedures
History of constrictive pericarditis
Previously placed coronary artery bypass grafts (CABG) or anticipated need for coronary artery bypass grafting
Not a candidate for cardiopulmonary bypass
Anatomical mitral valve regurgitation of 2+ or greater at the time of enrollment
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%
Cardiac or thoracic condition that might require operative correction. Cardiac transplantation is not included in this exclusion criterion.
Other elective surgical procedure at the time of the index hospitalization or within 30 days, whichever is longer

Other

Any other medical condition that, in the judgment of the investigator, makes the patient a poor candidate for this procedure
Currently enrolled or has participated in the last 30 days in another therapeutic or interventional clinical study
Unwilling/unable to comply with follow-up
Unwilling/unable to give signed informed consent

Study is for people with:

Heart Failure

Phase:

Phase 2

Estimated Enrollment:

220

Study ID:

NCT00382863

Recruitment Status:

Terminated

Sponsor:

Paracor Medical, Inc

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There are 35 Locations for this study

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University of Alabama Birmingham
Birmingham Alabama, 35294, United States
USC Keck School of Medicine
Los Angeles California, 90033, United States
University of California, San Francisco, Medical Center
San Francisco California, 94143, United States
University of Colorado Health Sciences Center
Aurora Colorado, 80045, United States
Christiana Care Health System
Newark Delaware, 19718, United States
University of Florida
Gainesville Florida, 32610, United States
Emory University
Atlanta Georgia, 30322, United States
Midwest Heart Foundation
Lombard Illinois, 60148, United States
St. Vincent Hospital and Health Services
Indianapolis Indiana, 46260, United States
Genesis Medical Center
Davenport Iowa, 52803, United States
University of Maryland, Division of Cardiology
Baltimore Maryland, 21201, United States
Caritas St. Elizabeth's Medical Center
Boston Massachusetts, 02135, United States
Wayne State University/ Oakwood Hospital
Detroit Michigan, 48201, United States
Minneapolis VA Medical Center
Minneapolis Minnesota, 55417, United States
St. Paul Heart Clinic
St. Paul Minnesota, 55102, United States
Mid America Heart Institute
Kansas City Missouri, 64111, United States
BryanLGH Heart Improvement Program
Lincoln Nebraska, 68506, United States
Morristown Memorial Hospital
Morristown New Jersey, 07962, United States
Montefiore Medical Center
Bronx New York, 10467, United States
University of Rochester Medical Center
Rochester New York, 14642, United States
The Lindner Clinical Trial Center
Cincinnati Ohio, 45219, United States
The Ohio State University Medical Center
Columbus Ohio, 43210, United States
Oklahoma Heart Hospital
Oklahoma City Oklahoma, 73120, United States
Penn State Milton S. Hershey Medical Center
Hershey Pennsylvania, 17033, United States
Allegheny General Hospital
Pittsburgh Pennsylvania, 15212, United States
The Stern Cardiovascular Center
Germantown Tennessee, 38138, United States
Tennessee Cardiovascular Research Institute
Nashville Tennessee, 37205, United States
Intermountain Medical Center
Murray Utah, 84107, United States
Inova Heart & Vascular Institute/ Fairfax Hospital
Falls Church Virginia, 22042, United States
University of Calgary
Calgary Alberta, T2N 4, Canada
St. Paul's Hospital
Vancouver British Columbia, V6Z 1, Canada
St. Boniface General Hospital
Winnipeg Manitoba, R2H 2, Canada
London Health Sciences Centre
London Ontario, N6A 5, Canada
Toronto General Hospital
Toronto Ontario, M5G 2, Canada
McGill University Hospital Centre
Montreal Quebec, H3A 1, Canada
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How clear is this clinincal trial information?

Study is for people with:

Heart Failure

Phase:

Phase 2

Estimated Enrollment:

220

Study ID:

NCT00382863

Recruitment Status:

Terminated

Sponsor:


Paracor Medical, Inc

How clear is this clinincal trial information?

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