Last updated on June 2009

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

Brief description of study

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.

Detailed Study 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.

Clinical Study Identifier: NCT00630266

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Maria Ansari, MD

Kaiser Permanente Northern California Heart Transplant Program
Santa Clara, CA United States
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Antone Tatooles, MD

Advocate Christ Medical Center
Oak Lawn, IL United States
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Steven F Bolling, MD

University of Michigan
Ann Arbor, MI United States
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Barbara Czerska, MD

Henry Ford Hospital
Detroit, MI United States
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Steven Krueger, MD

BryanLGH Medical Center
Lincoln, NE United States
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Kaliprasad N Ayala, MD

Nebraska Heart Institute
Lincoln, NE United States
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David A Baran, MD

Newark Beth Israel
Newark, NJ United States
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Nicholas Smedira, MD

Cleveland Clinic Foundation
Cleveland, OH United States
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Roy Small, MD

Lancaster General Hospital
Lancaster, PA United States
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Y. Joseph Woo, MD

Hospital of the University of Pennsylvania
Philadelphia, PA United States
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Ross Zimmer, MD

PENN-Presbyterian Medical Center
Philadelphia, PA United States
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Nadia Giannetti, MD

Royal Victoria Hospital, McGill University
Montreal, QC Canada
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