Overview

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

Status:
Terminated

Trial end date:
2012-05-01

Target enrollment:
0

Participant gender:
All

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.

Phase:

Phase 2/Phase 3

Accepts Healthy Volunteers?

Details

Lead Sponsor:

Paracor Medical, Inc

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 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

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