Clinical trial NCT00382863: Prospective Evaluation of Elastic Restraint to LESSen the Effects of Heart Failure (PEERLESS-HF) Trial
Official title: Prospective Evaluation of Elastic Restraint to LESSen the Effects of Heart Failure (PEERLESS-HF) Trial
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
PHASE3
Conditions: Heart Failure
Keywords: heart failure
cardiac support
Paracor
HeartNet
PEERLESS-HF
Lead sponsor: Paracor Medical, Inc
Sponsor class: INDUSTRY
First posted: 2006-10-02
Enrollment: 220
Sex: ALL
Minimum age (years): 18
Maximum age (years): 74
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Responder Analysis - Peak Oxygen Uptake (Peak VO2)
timeFrame: Baseline to 6 months
measure: Responder Analysis - Six (6) Minute Walk (6MW) Distance
timeFrame: Baseline to 6 months
measure: Responder Analysis - Minnesota Living With Heart Failure (MLWHF) Quality of Life Overall Score
timeFrame: baseline to 6 months
measure: Number of Participant Deaths
timeFrame: 12 months
Secondary outcomes:
measure: Change in New York Heart Association (NYHA) Functional Class
timeFrame: baseline to 6 months
measure: Change in Quality of Life as Measured by Kansas City Cardiomyopathy Questionnaire (KCCQ)
timeFrame: baseline to 6 months
measure: Change in Left Ventricular Mass
timeFrame: baseline to 6 months
measure: Responder Analysis - Peak Oxygen Uptake (Peak VO2)
timeFrame: baseline to 12 months
measure: Responder Analysis - Six (6) Minute Walk (6MW) Distance
timeFrame: baseline to 12 Months
measure: Responder Analysis - Minnesota Living With Heart Failure (MLWHF) Quality of Life Overall Score
timeFrame: baseline to 12 months
measure: Heart Failure Hospitalization - Actuarial Analysis
timeFrame: 12 months
measure: Change in Left Ventricular End Diastolic Volume
timeFrame: baseline to 6 months
measure: Change in Left Ventricular End Systolic Volume
timeFrame: baseline to 6 months
measure: Change in Ejection Fraction
timeFrame: baseline to 6 months
measure: Change in Left Ventricular End Diastolic Diameter
timeFrame: baseline to 6 months
measure: Change in Left Ventricular End Systolic Diameter
timeFrame: baseline to 6 months
measure: Technical Success (Number of Treatment Arm Participants Successfully Implanted)
timeFrame: 1 day
measure: Heart Failure Death
timeFrame: 12 months
measure: Heart Failure Death - Actuarial Analysis
timeFrame: 12 months
measure: Heart Failure Hospitalization
timeFrame: 12 months
measure: All-Cause Hospitalization
timeFrame: 12 months
measure: All-Cause Hospitalization - Actuarial Analysis
timeFrame: 12 months
measure: Participants Experiencing Serious Adverse Events
timeFrame: 12 months
measure: Serious Adverse Events - Actuarial Analysis
timeFrame: 12 months
measure: Days Alive Out of Hospital
timeFrame: 12 months
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama Birmingham
state: Alabama
city: Los Angeles
country: United States
facility: USC Keck School of Medicine
state: California
city: San Francisco
country: United States
facility: University of California, San Francisco, Medical Center
state: California
city: Aurora
country: United States
facility: University of Colorado Health Sciences Center
state: Colorado
city: Newark
country: United States
facility: Christiana Care Health System
state: Delaware
city: Gainesville
country: United States
facility: University of Florida
state: Florida
city: Atlanta
country: United States
facility: Emory University
state: Georgia
city: Lombard
country: United States
facility: Midwest Heart Foundation
state: Illinois
city: Indianapolis
country: United States
facility: St. Vincent Hospital and Health Services
state: Indiana
city: Davenport
country: United States
facility: Genesis Medical Center
state: Iowa
city: Baltimore
country: United States
facility: University of Maryland, Division of Cardiology
state: Maryland
city: Boston
country: United States
facility: Caritas St. Elizabeth's Medical Center
state: Massachusetts
city: Detroit
country: United States
facility: Wayne State University/ Oakwood Hospital
state: Michigan
city: Minneapolis
country: United States
facility: Minneapolis VA Medical Center
state: Minnesota
city: St. Paul
country: United States
facility: St. Paul Heart Clinic
state: Minnesota
city: Kansas City
country: United States
facility: Mid America Heart Institute
state: Missouri
city: Lincoln
country: United States
facility: BryanLGH Heart Improvement Program
state: Nebraska
city: Morristown
country: United States
facility: Morristown Memorial Hospital
state: New Jersey
city: Bronx
country: United States
facility: Montefiore Medical Center
state: New York
city: Rochester
country: United States
facility: University of Rochester Medical Center
state: New York
city: Cincinnati
country: United States
facility: The Lindner Clinical Trial Center
state: Ohio
city: Columbus
country: United States
facility: The Ohio State University Medical Center
state: Ohio
city: Oklahoma City
country: United States
facility: Oklahoma Heart Hospital
state: Oklahoma
city: Hershey
country: United States
facility: Penn State Milton S. Hershey Medical Center
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Allegheny General Hospital
state: Pennsylvania
city: Germantown
country: United States
facility: The Stern Cardiovascular Center
state: Tennessee
city: Nashville
country: United States
facility: Tennessee Cardiovascular Research Institute
state: Tennessee
city: Murray
country: United States
facility: Intermountain Medical Center
state: Utah
city: Falls Church
country: United States
facility: Inova Heart & Vascular Institute/ Fairfax Hospital
state: Virginia
city: Calgary
country: Canada
facility: University of Calgary
state: Alberta
city: Vancouver
country: Canada
facility: St. Paul's Hospital
state: British Columbia
city: Winnipeg
country: Canada
facility: St. Boniface General Hospital
state: Manitoba
city: London
country: Canada
facility: London Health Sciences Centre
state: Ontario
city: Toronto
country: Canada
facility: Toronto General Hospital
state: Ontario
city: Montreal
country: Canada
facility: McGill University Hospital Centre
state: Quebec
Study officials:
affiliation: Chief, Division of Cardiovascular Medicine, The Ohio State University
name: William T. Abraham, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.