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

Heart Failure Clinical Trial

— PEERLESS-HF  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00382863
• Other study ID #: 200
• Status: Terminated
• Phase: Phase 2/Phase 3
• First received: September 28, 2006
• Last updated: June 7, 2012
• Start date: October 2006
• Est. completion date: May 2012

Study information

• Verified date: June 2012
• Source: Paracor Medical, Inc
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 220
• Est. completion date: May 2012
• Est. primary completion date: May 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 74 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Heart Failure

Intervention

Device:
• HeartNet Ventricular Support System
The HeartNet Implant is placed on the epicardial surface of the heart surrounding both the left and right ventricles.

Drug:
• 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.

Locations

Country	Name	City	State
Canada	University of Calgary	Calgary	Alberta
Canada	London Health Sciences Centre	London	Ontario
Canada	McGill University Hospital Centre	Montreal	Quebec
Canada	Toronto General Hospital	Toronto	Ontario
Canada	St. Paul's Hospital	Vancouver	British Columbia
Canada	St. Boniface General Hospital	Winnipeg	Manitoba
United States	Emory University	Atlanta	Georgia
United States	University of Colorado Health Sciences Center	Aurora	Colorado
United States	University of Maryland, Division of Cardiology	Baltimore	Maryland
United States	University of Alabama Birmingham	Birmingham	Alabama
United States	Caritas St. Elizabeth's Medical Center	Boston	Massachusetts
United States	Montefiore Medical Center	Bronx	New York
United States	The Lindner Clinical Trial Center	Cincinnati	Ohio
United States	The Ohio State University Medical Center	Columbus	Ohio
United States	Genesis Medical Center	Davenport	Iowa
United States	Wayne State University/ Oakwood Hospital	Detroit	Michigan
United States	Inova Heart & Vascular Institute/ Fairfax Hospital	Falls Church	Virginia
United States	University of Florida	Gainesville	Florida
United States	The Stern Cardiovascular Center	Germantown	Tennessee
United States	Penn State Milton S. Hershey Medical Center	Hershey	Pennsylvania
United States	St. Vincent Hospital and Health Services	Indianapolis	Indiana
United States	Mid America Heart Institute	Kansas City	Missouri
United States	BryanLGH Heart Improvement Program	Lincoln	Nebraska
United States	Midwest Heart Foundation	Lombard	Illinois
United States	USC Keck School of Medicine	Los Angeles	California
United States	Minneapolis VA Medical Center	Minneapolis	Minnesota
United States	Morristown Memorial Hospital	Morristown	New Jersey
United States	Intermountain Medical Center	Murray	Utah
United States	Tennessee Cardiovascular Research Institute	Nashville	Tennessee
United States	Christiana Care Health System	Newark	Delaware
United States	Oklahoma Heart Hospital	Oklahoma City	Oklahoma
United States	Allegheny General Hospital	Pittsburgh	Pennsylvania
United States	University of Rochester Medical Center	Rochester	New York
United States	University of California, San Francisco, Medical Center	San Francisco	California
United States	St. Paul Heart Clinic	St. Paul	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
Paracor Medical, Inc

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Responder Analysis - Peak Oxygen Uptake (Peak VO2)	A participant was considered a "responder" if cardiopulmonary exercise testing demonstrated an improvement in peak VO2 of at least 1.0 ml/kg/min at 6 months as compared to baseline.	Baseline to 6 months	No
Primary	Responder Analysis - Six (6) Minute Walk (6MW) Distance	A participant was considered a "responder" if 6MW distance at 6 months was at least 45 meters more than at baseline.	Baseline to 6 months	No
Primary	Responder Analysis - Minnesota Living With Heart Failure (MLWHF) Quality of Life Overall Score	A participant was considered a "responder" if the MLHF overall score had improved by at least 7 points at 6 months as compared to baseline. THE MLHF questionnaire evaluates the impact of heart failure (HF) on a subject's physical, emotional, social and mental aspects of quality of life. Each of 21 questions about how much HF impacts daily activities is scored from 0-no impact to 5-very much (overall score can range from 0 to 105). Improvement is indicated by a decrease in score.	baseline to 6 months	No
Primary	Number of Participant Deaths	Total number of participants who died within 12 months of enrollment into the trial.	12 months	Yes
Secondary	Change in New York Heart Association (NYHA) Functional Class	Change in NYHA functional class between baseline and 6 months. "Maintained" means the participant's functional class remained the same as baseline. "Improved" means the participant's functional class improved (became lower in number) by at least one class. "Worsened" means the participant's functional class deteriorated (became higher in number) by at least one class.	baseline to 6 months	No
Secondary	Change in Quality of Life as Measured by Kansas City Cardiomyopathy Questionnaire (KCCQ)	The KCCQ is a 23-item questionnaire that quantifies physical function, symptoms, social function, self-efficacy/knowledge and quality of life. Scores range from 0 to 100, where higher scores reflect better health status. For this outcome measure, the difference between each participant's baseline and 6-month KCCQ scores was calculated. The mean change for each treatment arm is presented.	baseline to 6 months	No
Secondary	Change in Left Ventricular Mass	The difference between each participant's baseline and 6-month echocardiographic measure of left ventricular mass was calculated. The median change for each treatment arm is presented. A decrease in mass is associated with an improvement in the participant's structural heart failure.	baseline to 6 months	No
Secondary	Responder Analysis - Peak Oxygen Uptake (Peak VO2)	A participant was considered a "responder" if cardiopulmonary exercise testing demonstrated an improvement in peak VO2 of at least 1.0 ml/kg/min at 12 months as compared to baseline.	baseline to 12 months	No
Secondary	Responder Analysis - Six (6) Minute Walk (6MW) Distance	A participant was considered a "responder" if 6MW distance at 12 months was at least 45 meters more than at baseline.	baseline to 12 Months	No
Secondary	Responder Analysis - Minnesota Living With Heart Failure (MLWHF) Quality of Life Overall Score	A participant was considered a "responder" if the MLHF overall score had improved by at least 7 points at 12 months as compared to baseline. THE MLHF questionnaire evaluates the impact of heart failure (HF) on a subject's physical, emotional, social and mental aspects of quality of life. Each of 21 questions about how much HF impacts daily activities is scored from 0-no impact to 5-very much (overall score can range from 0 to 105). Improvement is indicated by a decrease in score.	baseline to 12 months	No
Secondary	Heart Failure Hospitalization - Actuarial Analysis	Kaplan-Meier actuarial analysis of heart failure hospitalization (as classified by an independent Clinical Events Committee) within the first 12 months after enrollment	12 months	Yes
Secondary	Change in Left Ventricular End Diastolic Volume	The difference between each participant's baseline and 6-month echocardiographic measure of left ventricular end diastolic volume was calculated. The median change for each treatment arm is presented. A decrease in volume is associated with an improvement in the participant's structural heart failure.	baseline to 6 months	No
Secondary	Change in Left Ventricular End Systolic Volume	The difference between each participant's baseline and 6-month echocardiographic measure of left ventricular end systolic volume was calculated. The median change for each treatment arm is presented. A decrease in volume indicates an improvement in the participant's structural heart failure.	baseline to 6 months	No
Secondary	Change in Ejection Fraction	The difference between each participant's baseline and 6-month echocardiographic measure of left ventricular ejection fraction was calculated. The median change for each treatment arm is presented.	baseline to 6 months	No
Secondary	Change in Left Ventricular End Diastolic Diameter	The difference between each participant's baseline and 6-month echocardiographic measure of left ventricular end diastolic diameter was calculated. The median change for each treatment arm is presented. A decrease in diameter indicates an improvement in the participant's structural heart failure.	baseline to 6 months	No
Secondary	Change in Left Ventricular End Systolic Diameter	The difference between each participant's baseline and 6-month echocardiographic measure of left ventricular end systolic diameter was calculated. The median change for each treatment arm is presented. A decrease in diameter indicates an improvement in the participant's structural heart failure.	baseline to 6 months	No
Secondary	Technical Success (Number of Treatment Arm Participants Successfully Implanted)	"Technical success" refers to the ability to successfully deliver a device onto the epicardial surface and leave the device in a satisfactory position. Participants who did not undergo an implant procedure were excluded from this analysis.	1 day	No
Secondary	Heart Failure Death	Number of participants who died within 12 months of enrolling in the study and whose cause of death was classified, by an independent Clinical Events Committee, as heart failure	12 months	Yes
Secondary	Heart Failure Death - Actuarial Analysis	Kaplan-Meier actuarial time-to-event analysis of deaths classified, by an independent Clinical Events Committee, as due to heart failure	12 months	Yes
Secondary	Heart Failure Hospitalization	Number of participants who experienced a heart failure hospitaliz (as classified by an independent Clinical Events Committee) within the first 12 months after enrollment.	12 months	Yes
Secondary	All-Cause Hospitalization	Number of participants who experienced a hospitalization (for any cause) within the first 12 months after enrollment. Within the Treatment Arm, hospitalization for the implant procedure was not included in this analysis.	12 months	Yes
Secondary	All-Cause Hospitalization - Actuarial Analysis	Kaplan-Meier actuarial time-to-first-event analysis of all-cause hospitalizations	12 months	Yes
Secondary	Participants Experiencing Serious Adverse Events	Number of participants who experienced a serious adverse event (as classified by an independent Clinical Events Committee) within the first 12 months after enrollment	12 months	Yes
Secondary	Serious Adverse Events - Actuarial Analysis	Kaplan-Meier actuarial time-to-first-event analysis of serious adverse events	12 months	Yes
Secondary	Days Alive Out of Hospital	Median number of days participants were not hospitalized within the first 12 months after enrollment. Within the Treatment Arm, hospitalization for the implant procedure was not included in this analysis.	12 months	Yes