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

June 16, 2009 updated by: Acorn Cardiovascular, Inc.

Clinical Evaluation of Acorn CorCap Cardiac Support Device Concomitant to MVR - A Confirmatory Trial

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

50

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

    • Quebec
      • Montreal, Quebec, Canada, H3A 1A1
        • Recruiting
        • Royal Victoria Hospital, McGill University
        • Contact:
        • Principal Investigator:
          • Renzo Cecere, MD
        • Principal Investigator:
          • Nadia Giannetti, MD
    • California
      • Santa Clara, California, United States, 95051
        • Recruiting
        • Kaiser Permanente Northern California Heart Transplant Program
        • Contact:
        • Principal Investigator:
          • Dana Weisshaar, MD
        • Principal Investigator:
          • Mario Pompili, MD
        • Principal Investigator:
          • Vic Melikian, MD
        • Principal Investigator:
          • Jay LaBourene, MD
        • Principal Investigator:
          • Maria Ansari, MD
    • Illinois
      • Oak Lawn, Illinois, United States, 60453
        • Recruiting
        • Advocate Christ Medical Center
        • Contact:
        • Principal Investigator:
          • Pat Pappas, MD
        • Principal Investigator:
          • Antone Tatooles, MD
    • Michigan
      • Ann Arbor, Michigan, United States, 48109-5864
        • Recruiting
        • University of Michigan
        • Contact:
        • Principal Investigator:
          • Steven F Bolling, MD
      • Detroit, Michigan, United States, 48202
        • Recruiting
        • Henry Ford Hospital
        • Contact:
        • Principal Investigator:
          • Robert Brewer, MD
        • Principal Investigator:
          • Hassan W. Nemeh, MD
        • Principal Investigator:
          • Barbara Czerska, MD
    • Nebraska
      • Lincoln, Nebraska, United States, 68526
        • Recruiting
        • Nebraska Heart Institute
        • Contact:
        • Principal Investigator:
          • James Wudel, MD
        • Principal Investigator:
          • Deepak Gangahar, MD
        • Principal Investigator:
          • Kaliprasad N Ayala, MD
      • Lincoln, Nebraska, United States, 68506
        • Recruiting
        • BryanLGH Medical Center
        • Contact:
        • Principal Investigator:
          • Edward Raines, MD
        • Principal Investigator:
          • Steven Krueger, MD
    • New Jersey
      • Newark, New Jersey, United States, 07112
        • Recruiting
        • Newark Beth Israel
        • Contact:
        • Principal Investigator:
          • Mark J Zucker, MD, JD
        • Principal Investigator:
          • Margarita Camacho, MD
        • Principal Investigator:
          • Ravi Karanam, MD
        • Principal Investigator:
          • David A Baran, MD
    • Ohio
      • Cleveland, Ohio, United States, 44195
        • Recruiting
        • Cleveland Clinic Foundation
        • Contact:
          • Barb Gus, RN
          • Phone Number: 216-445-6552
          • Email: gusb@ccf.org
        • Principal Investigator:
          • Nicholas Smedira, MD
    • Pennsylvania
      • Lancaster, Pennsylvania, United States, 17603
        • Recruiting
        • Lancaster General Hospital
        • Contact:
        • Principal Investigator:
          • Jeff Cope, MD
        • Principal Investigator:
          • Roy Small, MD
      • Philadelphia, Pennsylvania, United States, 19104
        • Recruiting
        • Hospital of the University of Pennsylvania
        • Contact:
        • Principal Investigator:
          • Michael A Acker, MD
        • Principal Investigator:
          • Mariell Jessup, MD
        • Principal Investigator:
          • Y. Joseph Woo, MD
      • Philadelphia, Pennsylvania, United States, 19104
        • Recruiting
        • Penn-Presbyterian Medical Center
        • Principal Investigator:
          • Y. Joseph Woo, MD
        • Contact:
        • Principal Investigator:
          • Michael A. Acker, MD
        • Principal Investigator:
          • W. Clark Hargrove, MD
        • Principal Investigator:
          • Rohinton Morris, MD
        • Principal Investigator:
          • Ross Zimmer, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change in patient functional status as evaluated using the Minnesota Living with Heart Failure questionnaire
Time Frame: 6 month follow-up
6 month follow-up
Change in maximal exercise tolerance evaluated using cardiopulmonary exercise (CPX) testing (peak VO2 exercise test)
Time Frame: 6 Month follow-up
6 Month follow-up
Change in sub-maximal exercise tolerance as evaluated using the Six Minute Walk test.
Time Frame: 6 months
6 months
Number of patients who have died (all-cause) or had a re-hospitalization due to heart failure.
Time Frame: 6 months
6 months
Peri-operative mortality, death occuring within 30 days of baseline surgery.
Time Frame: 30 days
30 days

Secondary Outcome Measures

Outcome Measure
Time Frame
Rate of death and SAEs overall and for each specific type of event
Time Frame: 6 months
6 months
Change in patient functional status as evaluated using the Minnesota Living with Heart Failure Questionnaire
Time Frame: 12 months
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Randall Starling, MD, The Cleveland Clinic
  • 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: 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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2008

Primary Completion (Anticipated)

December 1, 2009

Study Registration Dates

First Submitted

February 27, 2008

First Submitted That Met QC Criteria

March 5, 2008

First Posted (Estimate)

March 6, 2008

Study Record Updates

Last Update Posted (Estimate)

June 18, 2009

Last Update Submitted That Met QC Criteria

June 16, 2009

Last Verified

June 1, 2009

More Information

Terms related to this study

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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