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Sponsored by: |
Acorn Cardiovascular, Inc. |
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Information provided by: | Acorn Cardiovascular, Inc. |
ClinicalTrials.gov Identifier: | NCT00630266 |
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.
Condition | Intervention | Phase |
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Heart Failure |
Device: CorCap CSD |
Phase II |
Study Type: | Interventional |
Study Design: | Supportive Care, Non-Randomized, Open Label, Single Group Assignment, Safety/Efficacy Study |
Official Title: | Clinical Evaluation of Acorn CorCap Cardiac Support Device Concomitant to MVR - A Confirmatory Trial |
Estimated Enrollment: | 50 |
Study Start Date: | January 2008 |
Estimated Primary Completion Date: | June 2009 (Final data collection date for primary outcome measure) |
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.
Ages Eligible for Study: | 18 Years to 80 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
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:
Exclusion Criteria:
Late stage heart failure with increased surgical risk as defined by the presence of four or more of the following:
Contact: Meegan Anderson, RN, BSN, MBA, CCRA | 651-260-4822 | meegan.anderson@acorncv.com |
United States, California | |
Kaiser Permanente Northern California Heart Transplant Program | Recruiting |
Santa Clara, California, United States, 95051 | |
Contact: Patricia Lockyer, RN (CAP) 408-851-3826 patricia.lockyer@kp.org | |
Principal Investigator: Dana Weisshaar, MD | |
Principal Investigator: Mario Pompili, MD | |
Principal Investigator: Vic Melikian, MD | |
Principal Investigator: Jay LaBourene, MD | |
Principal Investigator: Maria Ansari, MD | |
United States, Illinois | |
Advocate Christ Medical Center | Recruiting |
Oak Lawn, Illinois, United States, 60453 | |
Contact: Colleen Gallagher, RN, BSN 708-346-4044 ext 27 colleen.gallagher@advocatehealth.com | |
Principal Investigator: Pat Pappas, MD | |
Principal Investigator: Antone Tatooles, MD | |
United States, Michigan | |
University of Michigan | Recruiting |
Ann Arbor, Michigan, United States, 48109-5864 | |
Contact: Cathie Bloem 734-615-6170 bloem@med.umich.edu | |
Principal Investigator: Steven F Bolling, MD | |
Henry Ford Hospital | Recruiting |
Detroit, Michigan, United States, 48202 | |
Contact: Karen Leszczynski, RN 313-916-3520 kleszcz1@hfhs.org | |
Principal Investigator: Robert Brewer, MD | |
Principal Investigator: Hassan W. Nemeh, MD | |
Principal Investigator: Barbara Czerska, MD | |
United States, Nebraska | |
Nebraska Heart Institute | Recruiting |
Lincoln, Nebraska, United States, 68526 | |
Contact: Deb Baehr, LPN 402-328-3939 dbaehr@neheart.com | |
Principal Investigator: James Wudel, MD | |
Principal Investigator: Deepak Gangahar, MD | |
Principal Investigator: Kaliprasad N Ayala, MD | |
United States, New Jersey | |
Newark Beth Israel | Recruiting |
Newark, New Jersey, United States, 07112 | |
Contact: Laura Adams, RN 973-926-8451 ladams@sbhcs.com | |
Principal Investigator: Mark J Zucker, MD, JD | |
Principal Investigator: Margarita Camacho, MD | |
Principal Investigator: Ravi Karanam, MD | |
Principal Investigator: David A Baran, MD | |
United States, Ohio | |
Cleveland Clinic Foundation | Recruiting |
Cleveland, Ohio, United States, 44195 | |
Contact: Barb Gus, RN 216-445-6552 gusb@ccf.org | |
Principal Investigator: Randall Starling, MD | |
Principal Investigator: Nicholas Smedira, MD | |
United States, Pennsylvania | |
Hospital of the University of Pennsylvania | Recruiting |
Philadelphia, Pennsylvania, United States, 19104 | |
Contact: Jessica L Howard 215-410-6987 jessica.howard@uphs.upenn.edu | |
Principal Investigator: Michael A Acker, MD | |
Principal Investigator: Mariell Jessup, MD | |
Principal Investigator: Y. Joseph Woo, MD | |
PENN-Presbyterian Medical Center | Recruiting |
Philadelphia, Pennsylvania, United States, 19104 | |
Contact: Marsha R. Watts, RN, BSN 215-662-9595 marsha.watts@uphs.upenn.edu | |
Principal Investigator: Michael A. Acker, MD | |
Principal Investigator: Y. Joseph Woo, MD | |
Principal Investigator: W. Clark Hargrove, MD | |
Principal Investigator: Rohinton Morris, MD | |
Principal Investigator: Wilson Szeto, MD | |
Principal Investigator: Ross Zimmer, MD | |
Lancaster General Hospital | Recruiting |
Lancaster, Pennsylvania, United States, 17603 | |
Contact: Linda Bowman, RN, BS, CCRC 717-290-6681 ext 203 lbowman@lancasterheart.org | |
Principal Investigator: Jeff Cope, MD | |
Principal Investigator: Roy Small, MD | |
Canada, Quebec | |
Royal Victoria Hospital, McGill University | Recruiting |
Montreal, Quebec, Canada, H3A 1A1 | |
Contact: Charlene Barber, RN 514-934-1934 ext 36764 charlene.barber@muhc.mcgill.ca | |
Principal Investigator: Renzo Cecere, MD | |
Principal Investigator: Nadia Giannetti, MD |
Principal Investigator: | Steven F Bolling, MD | University of Michigan |
Principal Investigator: | Michael A Acker, MD | Hospital of the University of Pennsylvania, Cardiovascular Medicine; Penn-Presbyterian Medical Center |
Principal Investigator: | Mario Pompili, MD | Kaiser Permanente Northern California Heart Transplant Program |
Principal Investigator: | James Wudel, MD | Nebraska Heart Institute |
Principal Investigator: | Randall Starling, MD | The Cleveland Clinic |
Principal Investigator: | Mark J Zucker, MD, JD | Newark Beth Israel |
Principal Investigator: | Renzo Cecere, MD | Royal Victoria Hospital, McGill University |
Principal Investigator: | Pat Pappas, MD | Advocate Christ Medical Center |
Principal Investigator: | Robert Brewer, MD | Henry Ford Hospital |
Principal Investigator: | Jeff Cope, MD | Lancaster General Hospital |
Responsible Party: | Acorn Cardiovascular ( Steve Anderson, President ) |
Study ID Numbers: | 47-1389 |
Study First Received: | February 27, 2008 |
Last Updated: | January 22, 2009 |
ClinicalTrials.gov Identifier: | NCT00630266 History of Changes |
Health Authority: | United States: Food and Drug Administration |
Heart failure left ventricular dilation mitral valve repair mitral valve replacement |
Heart Failure Heart Diseases Dilatation, Pathologic |
Heart Failure Heart Diseases Cardiovascular Diseases |