Clinical trial NCT03600688: Edwards Cardioband European Post-Market Study, 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
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Mitral Regurgitation
Mitral Insufficiency
Mitral Repair
Mitral Valve
Annuloplasty
Edwards Cardioband
Lead sponsor: Edwards Lifesciences
Sponsor class: INDUSTRY
First posted: 2018-07-26
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Symptomatic patients with mitral regurgitation (MR).

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.

Eligibility 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

Primary outcomes:
measure: Procedure Success at discharge
timeFrame: Hospital discharge; approximately 2-8 days post-procedure
Secondary outcomes:
measure: Procedure Success
timeFrame: 30 days, 6months, 1, 2 and 3 years
measure: Major Adverse Events Rate
timeFrame: 30 days, 6months, 1, 2 and 3 years
measure: Change in Quality Of Life-KCCQ
timeFrame: 30 days, 6 months, 1, 2 and 3 years
measure: Change in Quality Of Life-EQ-5D-5L
timeFrame: 30 days, 6 months, 1, 2 and 3 years
Other outcomes:
Locations:
city: Bad Oeynhausen
country: Germany
facility: Herz- und Diabeteszentrum NRW Bad Oeynhausen
city: Berlin
country: Germany
facility: Berlin Charité - Campus Benjamin Franklin
city: Bonn
country: Germany
facility: Universitätsklinikum Bonn
city: Cologne
country: Germany
facility: Herzzentrum UniKlinik Köln
city: Dresden
country: Germany
facility: Herzzentrum Universitästklinik Dresden
city: Düsseldorf
country: Germany
facility: Düsseldorf University Hospital
city: Frankfurt am main
country: Germany
facility: Goethe-University Frankfurt - Surgery Center
city: Göttingen
country: Germany
facility: Universitätsmedizin Göttingen
city: Hamburg
country: Germany
facility: Asklepios Klinik St Georg
city: Mainz
country: Germany
facility: Universtitätsmedizin Mainz
city: Münster
country: Germany
facility: Universitätsklinikum Münster
city: Catania
country: Italy
facility: Policlinico Vittorio-Emanuelle
city: Massa
country: Italy
facility: Ospedale del Cuore G. Pasquinucci - Fondazione Toscana Gabreile Monasterio
city: Milano
country: Italy
facility: Ospedale San Raffaele
city: Pisa
country: Italy
facility: Azienda Ospedaliera Universitaria Pisana
city: San Donato Milanese
country: Italy
facility: Policlinico San Donato
city: Zürich
country: Switzerland
facility: University Hospital Zürich
Study officials:
affiliation: Herzzentrum UniKlinik Köln
name: Stephan Baldus, MD
role: PRINCIPAL_INVESTIGATOR
References: