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About
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.
Full 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.
Enrollment
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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:
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:
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Central trial contact
Meegan Anderson, RN, BSN, MBA, CCRA
Data sourced from clinicaltrials.gov
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