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

Sponsor

Acorn Cardiovascular, Inc. (Industry)

Overall Status

Unknown status

CT.gov ID

NCT00630266

Collaborator

(none)

Enrollment

Locations

4.2

Patients Per Site

Study Details

Study Description

Brief Summary

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 or Disease	Intervention/Treatment	Phase
Heart Failure	Device: CorCap CSD	Phase 2

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 Design

Study Type:

Interventional

Anticipated Enrollment :

50 participants

Allocation:

Non-Randomized

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Supportive Care

Official Title:

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

Study Start Date :

Jan 1, 2008

Anticipated Primary Completion Date :

Dec 1, 2009

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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:

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).
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).
Diuretic at least "prn" (as occasion requires).
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:

LVEDD greater than 80 mm/m2
Resting systolic blood pressure (BP) less than or equal to 80 mm Hg (on clinical exam)
Atrial fibrillation at time of enrollment or paced rhythm with underlying atrial fibrillation
Heart failure greater than or equal to 8 years
6 minute walk less than or equal to 350 meters (1148 feet)
POV2 less than or equal to 13 ml/kg/min (CPX test)
Exercise induced increase in systolic BP less than 10 percent (CPX test)
Previous cardiac surgery
BUN greater than 100 mg/dl
Cachexia (clinical impression)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Kaiser Permanente Northern California Heart Transplant Program	Santa Clara	California	United States	95051
2	Advocate Christ Medical Center	Oak Lawn	Illinois	United States	60453
3	University of Michigan	Ann Arbor	Michigan	United States	48109-5864
4	Henry Ford Hospital	Detroit	Michigan	United States	48202
5	BryanLGH Medical Center	Lincoln	Nebraska	United States	68506
6	Nebraska Heart Institute	Lincoln	Nebraska	United States	68526
7	Newark Beth Israel	Newark	New Jersey	United States	07112
8	Cleveland Clinic Foundation	Cleveland	Ohio	United States	44195
9	Lancaster General Hospital	Lancaster	Pennsylvania	United States	17603
10	Hospital of the University of Pennsylvania	Philadelphia	Pennsylvania	United States	19104
11	PENN-Presbyterian Medical Center	Philadelphia	Pennsylvania	United States	19104
12	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