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Sponsored by: |
Myocor |
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Information provided by: | Myocor |
ClinicalTrials.gov Identifier: | NCT00512005 |
The purpose of this prospective, non-randomized, single-arm feasibility study is to evaluate safety and feasibility of the iCoapsys System in patients with functional mitral valve insufficiency caused by annular dilation and/or papillary muscle displacement.
Condition | Intervention | Phase |
---|---|---|
Mitral Valve Regurgitation Left Ventricular Dysfunction Heart Failure Mitral Insufficiency Mitral Incompetence Ischemic Heart Disease |
Device: Percutaneous mitral valve repair |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety Study |
Official Title: | Valvular and Ventricular Improvement Via iCoapsys Delivery (VIVID) Feasibility Study |
Estimated Enrollment: | 30 |
Study Start Date: | January 2008 |
Estimated Study Completion Date: | December 2013 |
Estimated Primary Completion Date: | December 2009 (Final data collection date for primary outcome measure) |
Functional MR is a frequent outcome of ischemic heart disease or dilated cardiomyopathy. Patients with functional MR generally have normal valvular structures complicated by left ventricular dysfunction. Left ventricular dysfunction will often create geometric distortions that prevent complete leaflet coaptation, rendering the valve incompetent. Changes that will induce functional MR may include (i) dyskinetic or akinetic wall segments, (ii) dilation of the valve annulus or (iii) dilation of the left ventricle leading to tethering of the chordae tendinae.
The iCoapsys Device is intended to treat patients with functional MR. The device is not indicated for patients with diseased or damaged valvular structures caused by rheumatic fever, degenerative diseases, endocarditis, infiltrative diseases or congenital disorders.
Ages Eligible for Study: | 18 Years to 85 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Key Inclusion Criteria:
Key Exclusion Criteria:
Contact: Cyril J. Schweich, MD | 763 494 5400 | schweich@myocor.com |
Contact: Adam K Hoyhtya, MS | 763 494 5430 | hoyhtya@myocor.com |
United States, Georgia | |
Emory University Hospital | Recruiting |
Atlanta, Georgia, United States, 30322 | |
Contact: Pamela Hyde, RN 404-712-7665 Pamela.hyde@emoryhealthcare.org | |
Principal Investigator: Peter Block, MD | |
United States, Illinois | |
Evanston Northwestern Healthcare - Evanston Hospital | Recruiting |
Evanston, Illinois, United States, 60201 | |
Contact: Claudia Focks 847-570-2366 cfocks@enh.org | |
Principal Investigator: Theodore Feldman, MD | |
United States, Kansas | |
Shawnee Mission Hospital | Recruiting |
Shawnee Mission, Kansas, United States, 66204 | |
Contact: Millie Salkind 913-671-6516 msalkind@kcheart.com | |
Principal Investigator: Paul Kramer, MD | |
United States, Minnesota | |
Abbott Northwestern Hospital | Recruiting |
Minneapolis, Minnesota, United States, 55440 | |
Contact: Sara Olson, RN 612-863-7601 sara.olson@allina.com | |
Principal Investigator: Wesley Pedersen, MD |
Responsible Party: | Myocor, Inc. ( Cyril J. Schweich, MD / VP of Clinical and Regulatory Affairs ) |
Study ID Numbers: | 030301 |
Study First Received: | August 6, 2007 |
Last Updated: | May 6, 2008 |
ClinicalTrials.gov Identifier: | NCT00512005 |
Health Authority: | United States: Food and Drug Administration |
Functional Mitral Regurgitation (FMR) Ischemic Mitral Regurgitation Less invasive repair Percutaneous MV repair |
Mitral Valve Repair Heart Failure Left Ventricular Dysfunction |
Ventricular Dysfunction Heart Failure Heart Diseases Myocardial Ischemia Vascular Diseases |
Ventricular Dysfunction, Left Ischemia Heart Valve Diseases Mitral Valve Insufficiency |
Cardiovascular Diseases |