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Edwards Cardioband European Post-Market Study, MiBAND

Sponsor
Edwards Lifesciences (Industry)
Overall Status
Recruiting
CT.gov ID
NCT03600688
Collaborator
(none)
200
Enrollment
17
Locations
66.8
Anticipated Duration (Months)
11.8
Patients Per Site
0.2
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Device: Edwards Cardioband System

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 Design

Study Type:
Observational
Anticipated Enrollment :
200 participants
Observational Model:
Cohort
Time Perspective:
Prospective
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
Actual Study Start Date :
Jun 6, 2018
Anticipated Primary Completion Date :
Dec 30, 2020
Anticipated Study Completion Date :
Dec 30, 2023

Outcome Measures

Primary Outcome Measures

  1. Procedure Success at discharge [Hospital discharge; approximately 2-8 days post-procedure]

    Reduction in Severity of Mitral Regurgitation at discharge

Secondary Outcome Measures

  1. Procedure Success [30 days, 6months, 1, 2 and 3 years]

    Reduction in Severity of Mitral Regurgitation

  2. Major Adverse Events Rate [30 days, 6months, 1, 2 and 3 years]

    Rate of Major Adverse Events

  3. Change in Quality Of Life-KCCQ [30 days, 6 months, 1, 2 and 3 years]

    Improvements in Quality Of Life as assessed by KCCQ

  4. 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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Herz- und Diabeteszentrum NRW Bad Oeynhausen Bad Oeynhausen Germany
2 Berlin Charité - Campus Benjamin Franklin Berlin Germany
3 Universitätsklinikum Bonn Bonn Germany
4 Herzzentrum UniKlinik Köln Cologne Germany
5 Herzzentrum Universitästklinik Dresden Dresden Germany
6 Düsseldorf University Hospital Düsseldorf Germany
7 Goethe-University Frankfurt - Surgery Center Frankfurt am main Germany
8 Universitätsmedizin Göttingen Göttingen Germany
9 Asklepios Klinik St Georg Hamburg Germany
10 Universtitätsmedizin Mainz Mainz Germany
11 Universitätsklinikum Münster Münster Germany
12 Policlinico Vittorio-Emanuelle Catania Italy
13 Ospedale del Cuore G. Pasquinucci - Fondazione Toscana Gabreile Monasterio Massa Italy
14 Ospedale San Raffaele Milano Italy
15 Azienda Ospedaliera Universitaria Pisana Pisa Italy
16 Policlinico San Donato San Donato Milanese Italy
17 University Hospital Zürich Zürich Switzerland

Sponsors and Collaborators

  • Edwards Lifesciences

Investigators

  • Principal Investigator: Stephan Baldus, MD, Herzzentrum UniKlinik Köln
  • Principal Investigator: Francesco Maisano, MD, University Hospital, Zürich

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Edwards Lifesciences
ClinicalTrials.gov Identifier:
NCT03600688
Other Study ID Numbers:
  • 2017-10
First Posted:
Jul 26, 2018
Last Update Posted:
Sep 23, 2020
Last Verified:
Sep 1, 2020
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Product Manufactured in and Exported from the U.S.:
No
Additional relevant MeSH terms:
Mitral Valve Insufficiency

Study Results

No Results Posted as of Sep 23, 2020