Heart Failure Clinical Trial
Official title:
Clinical Evaluation of Acorn CorCap Cardiac Support Device Concomitant to MVR - A Confirmatory Trial
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.
;
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Supportive Care
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