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Confirmation Trial of the Acorn CorCap Cardiac Support Device (CSD) at the Same Time as Mitral Valve Repair (MVR + CorCap)

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified June 2009 by Acorn Cardiovascular, Inc..
Recruitment status was:  Recruiting
Sponsor:
Information provided by:
Acorn Cardiovascular, Inc.
ClinicalTrials.gov Identifier:
NCT00630266
First received: February 27, 2008
Last updated: June 16, 2009
Last verified: June 2009
  Purpose

The purpose of this study to evaluate patients when they have an Acorn CorCapTM Cardiac Support Device (CSD) placed around their heart for the treatment of heart failure at the same time as their mitral valve surgery.

The CorCapTM CSD is intended to support the heart, potentially preventing further dilation that is associated with progressive heart failure, thereby potentially preserving or improving heart function.


Condition Intervention Phase
Heart Failure
Device: CorCap CSD
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: Clinical Evaluation of Acorn CorCap Cardiac Support Device Concomitant to MVR - A Confirmatory Trial

Resource links provided by NLM:


Further study details as provided by Acorn Cardiovascular, Inc.:

Primary Outcome Measures:
  • Change in patient functional status as evaluated using the Minnesota Living with Heart Failure questionnaire [ Time Frame: 6 month follow-up ] [ Designated as safety issue: No ]
  • Change in maximal exercise tolerance evaluated using cardiopulmonary exercise (CPX) testing (peak VO2 exercise test) [ Time Frame: 6 Month follow-up ] [ Designated as safety issue: No ]
  • Change in sub-maximal exercise tolerance as evaluated using the Six Minute Walk test. [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Number of patients who have died (all-cause) or had a re-hospitalization due to heart failure. [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
  • Peri-operative mortality, death occuring within 30 days of baseline surgery. [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Rate of death and SAEs overall and for each specific type of event [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
  • Change in patient functional status as evaluated using the Minnesota Living with Heart Failure Questionnaire [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 50
Study Start Date: January 2008
Estimated Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Intervention Details:
    Device: CorCap CSD
    The surgical procedure includes implantation of the CorCap CSD with concommitant mitral valve surgery through a sternotomy.
Detailed Description:

The Acorn CorCap Cardiac Support Device (CSD) is a new therapy for the treatment of heart failure that is designed to reduce left ventricular dilation, which is one of the most important pathophysiological mechanisms underlying the clinical syndrome of heart failure. The Acorn CorCap CSD is intended to reduce wall stress and support the heart, in order to prevent further dilation that is associated with progressive heart failure. It is designed to result in reduced left ventricular size and improve left ventricluar function, which should result in improved patient functional status.

The purpose of the study is to provide confirmatory data to demonstrate an improved benefit-risk profile in support of a Pre-Market Approval (PMA) application for the Acorn CorCap CSD when placed concomitant to Mitral Valve Repair/Replacement (MVR).

The primary efficacy objective is to evaluate patient functional status after 6 months of follow-up. The safety endpoint is perioperative (30 day) mortality.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Dilated cardiomyopathy of either ischemic or non-ischemic origin
  • Patients must be on stable, optimally uptitrated medical therapy recommended according to current guidelines as standard of care of heart failure therapy in the United States. This minimally includes:

    1. Angiotensin-converting enzyme inhibitors (ACE) or alternate if ACE not tolerated for greater than or equal to 1 month prior to enrollment (not required for patients with a mitral valve anomaly that is not likely to respond to medication and requires surgical intervention).
    2. Treatment with a beta-blocker, unless intolerant, for greater than or equal to 3 months prior to enrollment (not required for patients with a mitral valve anomaly that is not likely to respond to medication and requires surgical intervention).
    3. Diuretic at least "prn" (as occasion requires).
    4. Cardiac medications unchanged for greater than or equal to 1 month except for diuretic adjustments (not required for patients with a mitral valve anomaly that is not likely to respond to medications and requires surgical intervention).
  • Adult (18 to 80 years).
  • Indexed left ventricular end diastolic dimension (LVEDDi)between 30 mm/m2 and 40 mm/m2 as determined by transthoracic echocardiography.
  • Mitral regurgitation (MR) greater than or equal to 2+ and scheduled for mitral valve repair or replacement. Concomitant tricuspid valve repair or replacement (TVR) and/or atrial fibrillation ablation procedures will be permitted.
  • Left ventricular ejection fraction (LVEF) less than or equal to 45 percent via transthoracic echocardiography, cardiac catheterization, radionuclide scan, or magnetic resonance imaging
  • New York Heart Association Functional Class (NYHA) II, III or IV
  • Geographically available for follow-up
  • Signed Informed Consent

Exclusion Criteria:

  • Inability to reach maximal effort CPX test as defined by the CPX Core Lab
  • Planned cardiac surgical procedure other than MVR
  • Hypertrophic obstructive cardiomyopathy.
  • Significant cardiomegaly, which is estimated to exceed the largest available size of CorCap CSD.
  • Expectation of existing cardiothoracic adhesions that would cause an inability to gain complete circumferential access to the heart.
  • Existing patent CABG.
  • Candidates for surgical revascularization as determined by an angiogram. Patients with ischemic heart disease who have not had an angiogram within the past 3 years and in whom lesions amenable to revascularization cannot be excluded should have a repeat angiogram.
  • Any condition considered a contraindication for extracorporeal circulation.
  • Use of Intra aortic Balloon Pump (IABP), intravenous inotropic or vasoactive agents within 30 days prior to enrollment. Pre-operative hemodynamic optimization with IABP, IV inotropes or vasoactive agents may be permitted if it is scheduled to occur within 48 hours of planned index surgery.
  • Current or anticipated need for left ventricular assist device (LVAD) or cardiac replacement device.
  • Anticipated need for heart transplant within the next two years.
  • Acute myocardial infarction (AMI), unstable angina, or cerebral vascular accident (CVA) or Transient Ischemic Attack (TIA) within past 3 months.
  • Percutaneous coronary intervention (PCI) or transmyocardial laser revascularization (TMR or PMR) within the past 3 months.
  • Presence of arrhythmias causing hemodynamic instability, history of resuscitated sudden death without subsequent treatment with implantable defibrillator or amiodarone, or atrial fibrillation with a ventricular rate greater than 100 bpm on medication.
  • Co-morbid condition that reduces life expectancy to less than 1 year.
  • Active infection.
  • Pregnancy at the time of enrollment. (Women of child bearing potential must have a negative serum pregnancy test within two weeks prior to enrollment, or be using hormonal contraceptives or intrauterine devices.)
  • Enrolled in another investigational study that would confound interpretation of trial results.
  • Patients who participated as control patients in the previous CorCap PMA randomized trial.
  • Unable to comply with protocol-required follow-up (as judged by primary investigator or referring cardiologist).
  • Late stage heart failure with increased surgical risk as defined by the presence of four or more of the following:

    1. LVEDD greater than 80 mm/m2
    2. Resting systolic blood pressure (BP) less than or equal to 80 mm Hg (on clinical exam)
    3. Atrial fibrillation at time of enrollment or paced rhythm with underlying atrial fibrillation
    4. Heart failure greater than or equal to 8 years
    5. 6 minute walk less than or equal to 350 meters (1148 feet)
    6. POV2 less than or equal to 13 ml/kg/min (CPX test)
    7. Exercise induced increase in systolic BP less than 10 percent (CPX test)
    8. Previous cardiac surgery
    9. BUN greater than 100 mg/dl
    10. Cachexia (clinical impression)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00630266

Locations
United States, California
Kaiser Permanente Northern California Heart Transplant Program
Santa Clara, California, United States, 95051
United States, Illinois
Advocate Christ Medical Center
Oak Lawn, Illinois, United States, 60453
United States, Michigan
University of Michigan
Ann Arbor, Michigan, United States, 48109-5864
Henry Ford Hospital
Detroit, Michigan, United States, 48202
United States, Nebraska
BryanLGH Medical Center
Lincoln, Nebraska, United States, 68506
Nebraska Heart Institute
Lincoln, Nebraska, United States, 68526
United States, New Jersey
Newark Beth Israel
Newark, New Jersey, United States, 07112
United States, Ohio
Cleveland Clinic Foundation
Cleveland, Ohio, United States, 44195
United States, Pennsylvania
Lancaster General Hospital
Lancaster, Pennsylvania, United States, 17603
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
PENN-Presbyterian Medical Center
Philadelphia, Pennsylvania, United States, 19104
Canada, Quebec
Royal Victoria Hospital, McGill University
Montreal, Quebec, Canada, H3A 1A1
Sponsors and Collaborators
Acorn Cardiovascular, Inc.
Investigators
Principal Investigator: Steven F Bolling, MD University of Michigan
Principal Investigator: Michael A Acker, MD Hospital of the University of Pennsylvania, Cardiovascular Medicine; Penn-Presbyterian Medical Center
Principal Investigator: Mario Pompili, MD Kaiser Permanente Northern California Heart Transplant Program
Principal Investigator: James Wudel, MD Nebraska Heart Institute
Principal Investigator: Randall Starling, MD The Cleveland Clinic
Principal Investigator: Mark J Zucker, MD, JD Newark Beth Israel
Principal Investigator: Renzo Cecere, MD Royal Victoria Hospital, McGill University
Principal Investigator: Pat Pappas, MD Advocate Christ Medical Center
Principal Investigator: Robert Brewer, MD Henry Ford Hospital
Principal Investigator: Jeff Cope, MD Lancaster General Hospital
Principal Investigator: Edward Raines, MD BryanLGH Medical Center
  More Information

Responsible Party: Steve Anderson, President, Acorn Cardiovascular
ClinicalTrials.gov Identifier: NCT00630266     History of Changes
Other Study ID Numbers: 47-1389 
Study First Received: February 27, 2008
Last Updated: June 16, 2009
Health Authority: United States: Food and Drug Administration

Keywords provided by Acorn Cardiovascular, Inc.:
Heart failure
left ventricular dilation
mitral valve repair
mitral valve replacement

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on December 09, 2016