630266
Last Update Posted: 2009-06-18
Recruiting status is unknown
All Genders accepted | 18 Years-80 Years |
50 Estimated Participants | No Expanded Access |
Interventional Study | Does not accept healthy volunteers |
Confirmation Trial of the Acorn CorCap Cardiac Support Device (CSD) at the Same Time as Mitral Valve Repair
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.
Eligibility
Relevant conditions:
Heart Failure
If you aren't sure if you meet the criteria above speak to your healthcare professional. Criteria may be updated but not reflected here, do not hesitate to contact the trial if you think are close to fitting criteria.
Inclusion criteria
Exclusion criteria
locations
Contact Information
Overall Contact
Meegan Anderson, RN, BSN, MBA, CCRA
meegan.anderson@acorncv.com
651-260-4822
Data sourced from ClinicalTrials.gov