Edwards Cardioband European Post-Market Study, MiBAND

Mitral Regurgitation Clinical Trial

— MiBAND  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03600688
• Other study ID #: 2017-10
• Status: Active, not recruiting
• Start date: June 6, 2018
• Est. completion date: December 31, 2023

Study information

• Verified date: January 2023
• Source: Edwards Lifesciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

To demonstrate reduction of MR with durable performance and im-provements in functional status

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 200
• Est. completion date: December 31, 2023
• Est. primary completion date: December 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Annuloplasty
• Edwards Cardioband
• Mitral Insufficiency
• Mitral Regurgitation
• Mitral Repair
• Mitral Valve
• Mitral Valve Insufficiency

Intervention

Device:
• Edwards Cardioband System
Transcatheter mitral valve repair

Locations

Country	Name	City	State
Germany	Herz- und Diabeteszentrum NRW Bad Oeynhausen	Bad Oeynhausen
Germany	Berlin Charité - Campus Benjamin Franklin	Berlin
Germany	Universitätsklinikum Bonn	Bonn
Germany	Herzzentrum UniKlinik Köln	Cologne
Germany	Herzzentrum Universitästklinik Dresden	Dresden
Germany	Düsseldorf University Hospital	Düsseldorf
Germany	Goethe-University Frankfurt - Surgery Center	Frankfurt am main
Germany	Universitätsmedizin Göttingen	Göttingen
Germany	Asklepios Klinik St Georg	Hamburg
Germany	Universtitätsmedizin Mainz	Mainz
Germany	Universitätsklinikum Münster	Münster
Italy	Policlinico Vittorio-Emanuelle	Catania
Italy	Ospedale del Cuore G. Pasquinucci - Fondazione Toscana Gabreile Monasterio	Massa
Italy	Ospedale San Raffaele	Milano
Italy	Azienda Ospedaliera Universitaria Pisana	Pisa
Italy	Policlinico San Donato	San Donato Milanese
Switzerland	University Hospital Zürich	Zürich

Sponsors (1)

Lead Sponsor	Collaborator
Edwards Lifesciences

Countries where clinical trial is conducted

Germany,  Italy,  Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Procedure Success at discharge	Reduction in Severity of Mitral Regurgitation at discharge	Hospital discharge; approximately 2-8 days post-procedure
Secondary	Procedure Success	Reduction in Severity of Mitral Regurgitation	30 days, 6months, 1, 2 and 3 years
Secondary	Major Adverse Events Rate	Rate of Major Adverse Events	30 days, 6months, 1, 2 and 3 years
Secondary	Change in Quality Of Life-KCCQ	Improvements in Quality Of Life as assessed by KCCQ	30 days, 6 months, 1, 2 and 3 years
Secondary	Change in Quality Of Life-EQ-5D-5L	Improvements in Quality Of Life as assessed by EQ-5D-5L	30 days, 6 months, 1, 2 and 3 years