NCT03600688

Brief Summary

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

Trial Health

47
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2018

Longer than P75 for all trials

Geographic Reach
3 countries

17 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 6, 2018

Completed
9 days until next milestone

First Submitted

Initial submission to the registry

June 15, 2018

Completed
1 month until next milestone

First Posted

Study publicly available on registry

July 26, 2018

Completed
5.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2023

Completed
1 day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2023

Completed
Last Updated

January 26, 2023

Status Verified

January 1, 2023

Enrollment Period

5.6 years

First QC Date

June 15, 2018

Last Update Submit

January 25, 2023

Conditions

Mitral RegurgitationMitral InsufficiencyMitral RepairMitral ValveAnnuloplastyEdwards Cardioband

Outcome Measures

Primary Outcomes (1)

  • Procedure Success at discharge

    Reduction in Severity of Mitral Regurgitation at discharge

    Hospital discharge; approximately 2-8 days post-procedure

Secondary Outcomes (4)

  • Procedure Success

    30 days, 6months, 1, 2 and 3 years

  • Major Adverse Events Rate

    30 days, 6months, 1, 2 and 3 years

  • Change in Quality Of Life-KCCQ

    30 days, 6 months, 1, 2 and 3 years

  • Change in Quality Of Life-EQ-5D-5L

    30 days, 6 months, 1, 2 and 3 years

Interventions

Edwards Cardioband SystemDEVICE

Transcatheter mitral valve repair

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Symptomatic patients with mitral regurgitation (MR).

You may qualify if:

  • Age ≥ 18 years;
  • MR (≥ 2+ by echocardiography);
  • Patient is eligible to receive the Edwards Cardioband Mitral System

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (17)

Herz- und Diabeteszentrum NRW Bad Oeynhausen

Bad Oeynhausen, Germany

Location

Berlin Charité - Campus Benjamin Franklin

Berlin, Germany

Location

Universitätsklinikum Bonn

Bonn, Germany

Location

Herzzentrum UniKlinik Köln

Cologne, Germany

Location

Herzzentrum Universitästklinik Dresden

Dresden, Germany

Location

Düsseldorf University Hospital

Düsseldorf, Germany

Location

Goethe-University Frankfurt - Surgery Center

Frankfurt am Main, Germany

Location

Universitätsmedizin Göttingen

Göttingen, Germany

Location

Asklepios Klinik St Georg

Hamburg, Germany

Location

Universtitätsmedizin Mainz

Mainz, Germany

Location

Universitätsklinikum Münster

Münster, Germany

Location

Policlinico Vittorio-Emanuelle

Catania, Italy

Location

Ospedale del Cuore G. Pasquinucci - Fondazione Toscana Gabreile Monasterio

Massa, Italy

Location

Ospedale San Raffaele

Milan, Italy

Location

Azienda Ospedaliera Universitaria Pisana

Pisa, Italy

Location

Policlinico San Donato

San Donato Milanese, Italy

Location

University Hospital Zürich

Zurich, Switzerland

Location

MeSH Terms

Conditions

Mitral Valve Insufficiency

Condition Hierarchy (Ancestors)

Heart Valve DiseasesHeart DiseasesCardiovascular Diseases

Study Officials

  • Stephan Baldus, MD

    Herzzentrum UniKlinik Köln

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 15, 2018

First Posted

July 26, 2018

Study Start

June 6, 2018

Primary Completion

December 30, 2023

Study Completion

December 31, 2023

Last Updated

January 26, 2023

Record last verified: 2023-01

Locations

DE(11)IT(5)CH(1)