NCT03600688
Active, not recruiting
Not Applicable
Transcatheter Repair of Mitral Regurgitation With Cardioband System Post Market Study:A European Prospective, Multicenter Study to Assess Transcatheter Mitral Valve Repair With Edwards Cardioband System in Patients With Symptomatic MR
Edwards Lifesciences17 sites in 3 countries200 target enrollmentJune 6, 2018
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Mitral Regurgitation
- Sponsor
- Edwards Lifesciences
- Enrollment
- 200
- Locations
- 17
- Primary Endpoint
- Procedure Success at discharge
- Status
- Active, not recruiting
- Last Updated
- 3 years ago
Overview
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Age ≥ 18 years;
- •MR (≥ 2+ by echocardiography);
- •Patient is eligible to receive the Edwards Cardioband Mitral System
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
Outcomes
Primary Outcomes
Procedure Success at discharge
Time Frame: Hospital discharge; approximately 2-8 days post-procedure
Reduction in Severity of Mitral Regurgitation at discharge
Secondary Outcomes
- Procedure Success(30 days, 6months, 1, 2 and 3 years)
- Major Adverse Events Rate(30 days, 6months, 1, 2 and 3 years)
- Change in Quality Of Life-KCCQ(30 days, 6 months, 1, 2 and 3 years)
- Change in Quality Of Life-EQ-5D-5L(30 days, 6 months, 1, 2 and 3 years)
Study Sites (17)
Loading locations...
Similar Trials
Enrolling By Invitation
Not Applicable
Transcatheter Versus Standard Surgical Mitral Valve Operation for Secondary Mitral RegurgitationSevere Mitral Valve Regurgitation (Disorder)NCT05090540Centre Cardiologique du Nord600
Withdrawn
Phase 4
Transcatheter Repair of Mitral Regurgitation with Cardioband System Post Market Study (MiBAND): A European prospective, multicenter study to assess transcatheter mitral valve repair with Edwards Cardioband System in patients with symptomatic mitral regurgitation.NL-OMON49230Edwards Lifesciences, LCC5
Completed
Not Applicable
Surgical Correction of Moderate Ischemic Mitral RegurgitationModerate Ischemic Mitral RegurgitationNCT00394797Shaare Zedek Medical Center
Unknown
Not Applicable
Treatment of Concomitant Mitral Regurgitation by Mitral Valve Clipping in Patients With Successful Transcatheter Aortic Valve Implantation.Aortic StenosisMitral RegurgitationNCT04009434Technische Universität Dresden1,162
Terminated
Not Applicable
Impact of Mitral Regurgitation on Coronary Haemodynamics and Instantaneous Effect of Transcatheter Mitral Valve RepairMitral Valve InsufficiencyCoronary StenosisMitral RegurgitationCoronary Artery DiseaseNCT04245956University Hospital, Geneva1