NCT05332782

Brief Summary

This multinational, non-interventional, investigator-initiated, retrospective study aims to investigate outcomes of patients, who underwent mitral valve transcatheter edge-to-edge repair (M-TEER) for primary mitral regurgitation (PMR).

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
2,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2022

Longer than P75 for all trials

Geographic Reach
3 countries

6 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

First Submitted

Initial submission to the registry

March 1, 2022

Completed
Same day until next milestone

Study Start

First participant enrolled

March 1, 2022

Completed
2 months until next milestone

First Posted

Study publicly available on registry

April 18, 2022

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2025

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2026

Completed
Last Updated

April 18, 2022

Status Verified

April 1, 2022

Enrollment Period

2.8 years

First QC Date

March 1, 2022

Last Update Submit

April 11, 2022

Conditions

Mitral Regurgitation

Outcome Measures

Primary Outcomes (4)

  • All-cause mortality

    Incidence of death from any cause.

    12 months

  • Cardiovascular mortality

    Incidence of cardiovascular death, defined as death attributable to myocardial ischemia and infarction, heart failure, cardiac arrest because of other or unknown cause, or cerebrovascular accident.

    12 months

  • Rehospitalization for congestive heart failure

    Incidence of new-onset or worsening signs and symptoms of heart failure that required urgent therapy and resulted in hospitalization, e.g. as assessed by patient interviews or medical records.

    12 months

  • Re-do mitral valve procedure

    Incidence of unplanned surgical (mitral valve repair or replacement) or transcatheter re-intervention (re-do transcatheter edge-to-edge repair), e.g. as assessed by patient interviews or medical records.

    12 months

Secondary Outcomes (4)

  • Residual mitral regurgitation

    up to 30 days

  • Residual mitral regurgitation

    12 months

  • MVARC (Mitral Valve Academic Research Consortium) Technical success

    1 day (at exit from the catheterization laboratory)

  • Functional success

    1 day (at exit from the catheterization laboratory)

Study Arms (1)

M-TEER

Patients with primary mitral regurgitation undergoing mitral valve transcatheter edge-to-edge repair.

Eligibility Criteria

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

Consecutive patients undergoing transcatheter edge-to-edge repair for primary mitral regurgitation

You may qualify if:

  • clinically significant primary mitral regurgitation
  • patient underwent M-TEER
  • echocardiography data at baseline, procedure and follow-up
  • follow-up of at least 12 months

You may not qualify if:

  • age under 18 years

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

Montefiore Medical Center

New York, New York, 10467, United States

RECRUITING

Centre Hospitalier de Bordeaux

Bordeaux, France

RECRUITING

Université Lille, Inserm, Centre Hospitalier Universitaire de Lille

Lille, France

RECRUITING

University Hospital of Rennes, Centre Hospitalier de Rennes

Rennes, France

RECRUITING

University Heart & Vascular Center Hamburg

Hamburg, 20246, Germany

RECRUITING

Klinikum der Universität München

Munich, Germany

RECRUITING

MeSH Terms

Conditions

Mitral Valve Insufficiency

Condition Hierarchy (Ancestors)

Heart Valve DiseasesHeart DiseasesCardiovascular Diseases

Study Officials

  • Daniel Kalbacher, MD

    University Heart & Vascular Center Hamburg

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Benedikt Koell, MD

CONTACT

+4915222815230b.koell@uke.de

Sebastian Ludwig, MD

CONTACT

+491522816168se.ludwig@uke.de

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 1, 2022

First Posted

April 18, 2022

Study Start

March 1, 2022

Primary Completion

January 1, 2025

Study Completion

January 1, 2026

Last Updated

April 18, 2022

Record last verified: 2022-04

Data Sharing

IPD Sharing
Will not share

Locations

DE(2)FR(3)US(1)