Status:
TERMINATED
Prospective Evaluation of Elastic Restraint to LESSen the Effects of Heart Failure (PEERLESS-HF) Trial
Lead Sponsor:
Paracor Medical, Inc
Conditions:
Heart Failure
Eligibility:
All Genders
18-74 years
Phase:
PHASE2
PHASE3
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 improvemen...
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 conditio...
Eligibility Criteria
Inclusion
- 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 \<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
- 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
- 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
Key Trial Info
Start Date :
October 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2012
Estimated Enrollment :
220 Patients enrolled
Trial Details
Trial ID
NCT00382863
Start Date
October 1 2006
End Date
May 1 2012
Last Update
July 13 2012
Active Locations (35)
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1
University of Alabama Birmingham
Birmingham, Alabama, United States, 35294
2
USC Keck School of Medicine
Los Angeles, California, United States, 90033
3
University of California, San Francisco, Medical Center
San Francisco, California, United States, 94143
4
University of Colorado Health Sciences Center
Aurora, Colorado, United States, 80045