Edwards Cardioband European Post-Market Study, MiBAND (MiBAND)

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

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

Study Overview

• Status: Active, not recruiting
• Conditions: Mitral Regurgitation; Mitral Insufficiency; Mitral Repair; Mitral Valve; Annuloplasty; Edwards Cardioband
• Intervention / Treatment: 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 Type: Observational
• Enrollment (Anticipated): 200

Contacts and Locations

• Study Contact: Name: Edwards TMTT Clinical Affairs; Phone Number: +1 949 250 2500; Email: TMTT_clinical@edwards.com

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Symptomatic patients with mitral regurgitation (MR).

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Procedure Success at discharge	Reduction in Severity of Mitral Regurgitation at discharge	Hospital discharge; approximately 2-8 days post-procedure

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Procedure Success	Reduction in Severity of Mitral Regurgitation	30 days, 6months, 1, 2 and 3 years
Major Adverse Events Rate	Rate of Major Adverse Events	30 days, 6months, 1, 2 and 3 years
Change in Quality Of Life-KCCQ	Improvements in Quality Of Life as assessed by KCCQ	30 days, 6 months, 1, 2 and 3 years
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

Collaborators and Investigators

• Sponsor: Edwards Lifesciences
• Investigators: Principal Investigator: Stephan Baldus, MD, Herzzentrum Uniklinik Köln

Study record dates

Study Major Dates

• Study Start (Actual): June 6, 2018
• Primary Completion (Anticipated): December 30, 2023
• Study Completion (Anticipated): December 31, 2023

Study Registration Dates

• First Submitted: June 15, 2018
• First Submitted That Met QC Criteria: July 16, 2018
• First Posted (Actual): July 26, 2018

Study Record Updates

• Last Update Posted (Estimate): January 26, 2023
• Last Update Submitted That Met QC Criteria: January 25, 2023
• Last Verified: January 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Heart Valve Diseases; Mitral Valve Insufficiency
• Other Study ID Numbers: 2017-10

Drug and device information, study documents

• 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