Annuloplasty, Edwards Cardioband, Mitral Insufficiency, Mitral Regurgitation, Mitral Repair, Mitral Valve
Conditions
Brief summary
To demonstrate reduction of MR with durable performance and im-provements in functional status
Detailed description
MiBAND is a prospective, single arm, European post-market study to assess the safety and efficacy of the Edwards Cardioband system. Patients will be followed up at 30D, 6months, 1, 2 and 3 years.
Interventions
Transcatheter mitral valve repair
Sponsors
Edwards Lifesciences
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Main Inclusion Criteria: * Age ≥ 18 years; * MR (≥ 2+ by echocardiography); * Patient is eligible to receive the Edwards Cardioband Mitral System Main
Exclusion criteria
* Active bacterial endocarditis * Severe organic lesions with retracted chordae or congenital mal-formations with lack of valvular tissue * Heavily calcified annulus or leaflets * Patients in whom transesophageal echocardiography is contraindicated * Patients who cannot tolerate an anticoagulation/antiplatelet regimen * Patients with known severe reaction to contrast agents that cannot be adequately pre-medicated. * Pre-existing prosthetic heart valve or annuloplasty in the Mitral position * Life expectancy of less than twelve months * Patient is pregnant or lactating
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Procedure Success at discharge | Hospital discharge; approximately 2-8 days post-procedure | Reduction in Severity of Mitral Regurgitation at discharge |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Procedure Success | 30 days, 6months, 1, 2 and 3 years | Reduction in Severity of Mitral Regurgitation |
| Major Adverse Events Rate | 30 days, 6months, 1, 2 and 3 years | Rate of Major Adverse Events |
| Change in Quality Of Life-KCCQ | 30 days, 6 months, 1, 2 and 3 years | Improvements in Quality Of Life as assessed by KCCQ |
| Change in Quality Of Life-EQ-5D-5L | 30 days, 6 months, 1, 2 and 3 years | Improvements in Quality Of Life as assessed by EQ-5D-5L |
Countries
Germany, Italy, Switzerland
Outcome results
None listed