Mitral Regurgitation Mitral Insufficiency Annuloplasty Ring Mitral Valve Dysfunction Mitralis Regurgitatie Mitralis Insufficientie Annuloplastiek Ring Mitraal Klep Dysfunctioneren
Conditions
Interventions
Subject is screened and given Baseline assessments conform daily rourine for Open Heart Surgery. Baseline TTE will be done.
Procedure: patient is receives the DYANA ring during Open Heart Surgery. Pre
Sponsors
MiCardia Corporation
Primary (U.S.) Contact:
Jody L. Errandi M.S. CORMEDICS
Director of Clinical Research
MiCardia, Incorporated
30 Hughes, Suite 206
Irvine, CA 92618
U.S.A.
Phone: +1.949.951.4888
Fax: +1.949.756.4525
Email: jerrandi@micardia.com
Eligibility
Inclusion criteria
Inclusion criteria: 1. Patient requires mitral valve repair with or without concomitant procedures such as coronary artery bypass or another valve reconstruction or replacement; 2. patient has been diagnosed with a diseased natural valve, based on echocardiography and is a candidate for mitral valve repair; 3. patient is in satisfactory condition, based on the physical exam and investigator's experience, to be an average or better operative risk. (i.e., likely to survive one year postoperatively); 4. patient is geographically stable and willing to return to the implant center for follow-up visits; 5. Documentation signed and dated confirming that this patient has been adequately informed of his/her participation in the clinical study, and of what will be required of him/her, in order to comply with the protocol.
Exclusion criteria
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; 3. patient has an ejection fraction 2.0 mg/dl; 11. patient has had congestive heart failure within the past 6 months requiring surgical treatment; 12. patient has had a coronary artery ischemic event within the past 6 months requiring surgical treatment; 13. patient has a known life threatening, non-cardiac disease that will limit the patients life expectancy to less than one year; 14. patient is unable to take antiaggregant medications; 15. patient has a known untreatable allergy to contrast media or nickel; 16. patient has had a cerebral vascular event within the past 6 months; 17. patient is a prisoner (U.S.A. Only); 18. patient is participating in concomitant research studies of investigational products; 19. patient will not agree to return to the implant center for the required number of follow-up.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary safety endpoint is the occurrence of; 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. The primary efficacy endpoint is the ability to reduce mitral regurgitation to less than 2+ immediately following surgical implantation of the annuloplasty device. | — |
Secondary
| Measure | Time frame |
|---|---|
| The secondary safety endpoint is the occurrence of; 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. 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 the device. | — |
Contacts
Public ContactL. Duininck
Erasmus University Medical Center PO Box 2040
Outcome results
None listed