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

Status unconfirmed · Phase 2

Conditions studied: Heart Failure

In brief

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.

Key facts

Study ID

NCT00630266

Run by

Acorn Cardiovascular, Inc.

People needed

50

Starts

2008-01-01

Last updated by the study team

2009-06-18

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Kaiser Permanente Northern California Heart Transplant Program — Santa Clara, California, United States (enrolling)
• Advocate Christ Medical Center — Oak Lawn, Illinois, United States (enrolling)
• University of Michigan — Ann Arbor, Michigan, United States (enrolling)
• Henry Ford Hospital — Detroit, Michigan, United States (enrolling)
• BryanLGH Medical Center — Lincoln, Nebraska, United States (enrolling)
• Nebraska Heart Institute — Lincoln, Nebraska, United States (enrolling)
• Newark Beth Israel — Newark, New Jersey, United States (enrolling)
• Cleveland Clinic Foundation — Cleveland, Ohio, United States (enrolling)
• Lancaster General Hospital — Lancaster, Pennsylvania, United States (enrolling)
• Hospital of the University of Pennsylvania — Philadelphia, Pennsylvania, United States (enrolling)
• PENN-Presbyterian Medical Center — Philadelphia, Pennsylvania, United States (enrolling)
• Royal Victoria Hospital, McGill University — Montreal, Quebec, Canada (enrolling)

Full record on ClinicalTrials.gov

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