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

• ClinicalTrials.gov Identifier: NCT00630266
• Recruitment Status: Unknown
• First Posted: March 6, 2008
• Last Update Posted: June 18, 2009
• Sponsor: Acorn Cardiovascular, Inc.
• Information provided by: Acorn Cardiovascular, Inc.

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 (Clinical Trial)
• Estimated 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: January 2008
• Estimated Primary Completion Date: December 2009

Arms and Interventions

Intervention Details:

• Device: CorCap CSD
  The surgical procedure includes implantation of the CorCap CSD with concommitant mitral valve surgery through a sternotomy.

Outcome Measures

Primary Outcome Measures :

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

Secondary Outcome Measures :

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

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 80 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• 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

Contacts

Contact: Meegan Anderson, RN, BSN, MBA, CCRA; 651-260-4822; meegan.anderson@acorncv.com

Locations

United States, California

Kaiser Permanente Northern California Heart Transplant Program; Recruiting

Santa Clara, California, United States, 95051

Contact: Patricia Lockyer, RN (CAP) 408-851-3826 patricia.lockyer@kp.org

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

United States, Illinois

Advocate Christ Medical Center; Recruiting

Oak Lawn, Illinois, United States, 60453

Contact: Colleen Gallagher, RN, BSN 708-346-4044 ext 27 colleen.gallagher@advocatehealth.com

Principal Investigator: Pat Pappas, MD

Principal Investigator: Antone Tatooles, MD

United States, Michigan

University of Michigan; Recruiting

Ann Arbor, Michigan, United States, 48109-5864

Contact: Cathie Bloem 734-615-6170 bloem@med.umich.edu

Principal Investigator: Steven F Bolling, MD

Henry Ford Hospital; Recruiting

Detroit, Michigan, United States, 48202

Contact: Karen Leszczynski, RN 313-916-3520 kleszcz1@hfhs.org

Principal Investigator: Robert Brewer, MD

Principal Investigator: Hassan W. Nemeh, MD

Principal Investigator: Barbara Czerska, MD

United States, Nebraska

BryanLGH Medical Center; Recruiting

Lincoln, Nebraska, United States, 68506

Contact: Shari Harre, RN 402-483-3373 shari@bhi-1.com

Principal Investigator: Edward Raines, MD

Principal Investigator: Steven Krueger, MD

Nebraska Heart Institute; Recruiting

Lincoln, Nebraska, United States, 68526

Contact: Deb Baehr, LPN 402-328-3939 dbaehr@neheart.com

Principal Investigator: James Wudel, MD

Principal Investigator: Deepak Gangahar, MD

Principal Investigator: Kaliprasad N Ayala, MD

United States, New Jersey

Newark Beth Israel; Recruiting

Newark, New Jersey, United States, 07112

Contact: Laura Adams, RN 973-926-8451 ladams@sbhcs.com

Principal Investigator: Mark J Zucker, MD, JD

Principal Investigator: Margarita Camacho, MD

Principal Investigator: Ravi Karanam, MD

Principal Investigator: David A Baran, MD

United States, Ohio

Cleveland Clinic Foundation; Recruiting

Cleveland, Ohio, United States, 44195

Contact: Barb Gus, RN 216-445-6552 gusb@ccf.org

Principal Investigator: Randall Starling, MD

Principal Investigator: Nicholas Smedira, MD

United States, Pennsylvania

Lancaster General Hospital; Recruiting

Lancaster, Pennsylvania, United States, 17603

Contact: Linda Bowman, RN, BS, CCRC 717-290-6681 ext 203 lbowman@lancasterheart.org

Principal Investigator: Jeff Cope, MD

Principal Investigator: Roy Small, MD

Hospital of the University of Pennsylvania; Recruiting

Philadelphia, Pennsylvania, United States, 19104

Contact: Jessica L Howard 215-410-6987 jessica.howard@uphs.upenn.edu

Principal Investigator: Michael A Acker, MD

Principal Investigator: Mariell Jessup, MD

Principal Investigator: Y. Joseph Woo, MD

PENN-Presbyterian Medical Center; Recruiting

Philadelphia, Pennsylvania, United States, 19104

Contact: Marsha R. Watts, RN, BSN 215-662-9595 marsha.watts@uphs.upenn.edu

Principal Investigator: Michael A. Acker, MD

Principal Investigator: Y. Joseph Woo, MD

Principal Investigator: W. Clark Hargrove, MD

Principal Investigator: Rohinton Morris, MD

Principal Investigator: Wilson Szeto, MD

Principal Investigator: Ross Zimmer, MD

Canada, Quebec

Royal Victoria Hospital, McGill University; Recruiting

Montreal, Quebec, Canada, H3A 1A1

Contact: Charlene Barber, RN 514-934-1934 ext 36764 charlene.barber@muhc.mcgill.ca

Principal Investigator: Renzo Cecere, MD

Principal Investigator: Nadia Giannetti, MD

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
• Other Study ID Numbers: 47-1389
• First Posted: March 6, 2008
• Last Update Posted: June 18, 2009
• Last Verified: June 2009

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