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.
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
Allocation
NON_RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
50
The surgical procedure includes implantation of the CorCap CSD with concommitant mitral valve surgery through a sternotomy.
Kaiser Permanente Northern California Heart Transplant Program
Santa Clara, California, United States
RECRUITINGAdvocate Christ Medical Center
Oak Lawn, Illinois, United States
Change in patient functional status as evaluated using the Minnesota Living with Heart Failure questionnaire
Time frame: 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
Change in sub-maximal exercise tolerance as evaluated using the Six Minute Walk test.
Time frame: 6 months
Number of patients who have died (all-cause) or had a re-hospitalization due to heart failure.
Time frame: 6 months
Peri-operative mortality, death occuring within 30 days of baseline surgery.
Time frame: 30 days
Rate of death and SAEs overall and for each specific type of event
Time frame: 6 months
Change in patient functional status as evaluated using the Minnesota Living with Heart Failure Questionnaire
Time frame: 12 months
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
University of Michigan
Ann Arbor, Michigan, United States
RECRUITINGHenry Ford Hospital
Detroit, Michigan, United States
RECRUITINGBryanLGH Medical Center
Lincoln, Nebraska, United States
RECRUITINGNebraska Heart Institute
Lincoln, Nebraska, United States
RECRUITINGNewark Beth Israel
Newark, New Jersey, United States
RECRUITINGCleveland Clinic Foundation
Cleveland, Ohio, United States
RECRUITINGLancaster General Hospital
Lancaster, Pennsylvania, United States
RECRUITINGHospital of the University of Pennsylvania
Philadelphia, Pennsylvania, United States
RECRUITING...and 2 more locations