Heartvalve leakage Mitral valve regurgitation
Conditions
Interventions
Surgically placed annuloplasty Nitinol ring for the treatment of mitral
regurgitation (MR) with an intra-operative shape change option for
additional optimization.
Shape change will be achieved by RF
Sponsors
MiCardia Corporation, Jody L. Errandi M.S., Director of Clinical
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 1.This patient requires mitral valve repair with or without concomitant procedures such as coronary artery bypass or another valve reconstruction or replacement. 2.This patient has been diagnosed with a diseased natural valve, based on echocardiography and is a candidate for mitral valve repair. 3.This 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)
Exclusion criteria
Exclusion criteria: 1. This patient is less than eighteen (18) years of age. 2. This 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 who has heavily calcified annulus or leaflets. 4. reoperation
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, and myocardial infarction (MI) at 30 days post-procedure. The primary efficacy endpoint is 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, and 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. | — |
Countries
Netherlands
Outcome results
None listed