DYANA Study - Dynamic Annuloplasty System with Activation for the Treatment of Mitral Regurgitation.
- Conditions
- Mitral RegurgitationMitral InsufficiencyAnnuloplasty RingMitral Valve DysfunctionMitralis RegurgitatieMitralis InsufficientieAnnuloplastiek RingMitraal Klep Dysfunctioneren
- Registration Number
- NL-OMON24536
- Lead Sponsor
- MiCardia CorporationPrimary (U.S.) Contact: Jody L. Errandi M.S. CORMEDICS Director of Clinical Research MiCardia, Incorporated30 Hughes, Suite 206 Irvine, CA 92618 U.S.A. Phone: +1.949.951.4888 Fax: +1.949.756.4525 Email: jerrandi@micardia.com
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- Not specified
- Target Recruitment
- 15
Inclusion Criteria
1. Patient requires mitral valve repair with or without concomitant procedures such
as coronary artery bypass or another valve reconstruction or replacement;
Exclusion Criteria
1. Patient is less than eighteen (18) years of age;
2. patient has a non-cardiac major or progressive disease, which in the investigators experience produces an unacceptable increased risk to the patient, or results in a life expectancy of less than twelve months;
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The primary safety endpoint is the occurrence of;<br /> <br>death, endocarditis, ring dehiscence, systolic anterior motion (SAM), embolic event, pulmonary edema, heart block, arrhythmia, hemolysis, or myocardial infarction (MI) at 30 days post-procedure.<br /><br>The primary efficacy endpoint is the ability to reduce mitral regurgitation to less than 2+ immediately following surgical implantation of the annuloplasty device.
- Secondary Outcome Measures
Name Time Method The secondary safety endpoint is the occurrence of; <br /><br>death, endocarditis, ring dehiscence, systolic anterior motion (SAM), embolic event, pulmonary edema, heart block, arrhythmia, hemolysis or myocardial infarction (MI) at 6 months post-procedure.<br /><br>The secondary efficacy endpoint is the ability to further reduce residual regurgitation following annuloplasty ring implantation and /or to enhance coaptation distance using intra-operative activation of<br>the device.