Edwards Cardioband European Post-Market Study, MiBAND

Active, not recruiting

• Conditions: Mitral Insufficiency; Annuloplasty; Mitral Regurgitation; Mitral Valve; Mitral Repair; Edwards Cardioband

• Registration Number: NCT03600688
• Lead Sponsor: Edwards Lifesciences

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.

Study Timeline

• Study Start: 2018-06-06
• Study First Submitted: 2018-06-15
• Study First Submitted QC: 2018-07-16
• Study First Posted: 2018-07-26
• Status Verified: 2023-01
• Last Update Submitted: 2023-01-25
• Last Update Posted: 2023-01-26
• Primary Completion: 2023-12-30
• Study Completion: 2023-12-31

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 200

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Procedure Success at discharge	Hospital discharge; approximately 2-8 days post-procedure	Reduction in Severity of Mitral Regurgitation at discharge

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (17)

University Hospital Zürich; 🇨🇭 Zürich, Switzerland

Universitätsklinikum Bonn; 🇩🇪 Bonn, Germany

Herzzentrum UniKlinik Köln; 🇩🇪 Cologne, Germany

Berlin Charité - Campus Benjamin Franklin; 🇩🇪 Berlin, Germany

Herz- und Diabeteszentrum NRW Bad Oeynhausen; 🇩🇪 Bad Oeynhausen, Germany

Herzzentrum Universitästklinik Dresden; 🇩🇪 Dresden, Germany

Düsseldorf University Hospital; 🇩🇪 Düsseldorf, Germany

Goethe-University Frankfurt - Surgery Center; 🇩🇪 Frankfurt am main, Germany

Universitätsmedizin Göttingen; 🇩🇪 Göttingen, Germany

Universitätsklinikum Münster; 🇩🇪 Münster, Germany

Asklepios Klinik St Georg; 🇩🇪 Hamburg, Germany

Universtitätsmedizin Mainz; 🇩🇪 Mainz, Germany

Ospedale San Raffaele; 🇮🇹 Milano, Italy

Policlinico Vittorio-Emanuelle; 🇮🇹 Catania, Italy

Ospedale del Cuore G. Pasquinucci - Fondazione Toscana Gabreile Monasterio; 🇮🇹 Massa, Italy

Azienda Ospedaliera Universitaria Pisana; 🇮🇹 Pisa, Italy

Policlinico San Donato; 🇮🇹 San Donato Milanese, Italy