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CHoice of OptImal transCatheter trEatment for Mitral Insufficiency Registry

This study is a registry looking at the results for patients who have a procedure called transcatheter mitral valve replacement (TMVR) for mitral insufficiency (a heart valve problem where blood leaks backward). The registry will collect information from patients in real-world medical practice. To join, you must have significant mitral insufficiency, have been screened for TMVR, and have heart ultrasound (echocardiography) data. The study will look at how well the TMVR procedure works by checking if your mitral insufficiency is still significant after 12 months, and if you have any device-related problems within 30 days. The current status of this study is unclear.

Study design
This is an observational study that plans to include about 1000 participants. It is designed to collect information about patients undergoing TMVR in real-world settings.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
The study will follow participants for at least 30 days, with a primary check on mitral insufficiency at 12 months.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT04688190

CHoice of OptImal transCatheter trEatment for Mitral Insufficiency Registry

Recruiting
Not specifiedAges 18+Observational
Universitätsklinikum Hamburg-Eppendorf
~1,000 participants
Updated 2026-05-07 on ClinicalTrials.gov

At a glance

Recruiting sites
43 of 43 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Mitral insufficiency grade 2+ or more
Measured over 12 months
+1 more outcome measured

Conditions

Mitral Regurgitation
Mitral Valve Disease
Mitral Annular Calcification

Explore related trials

Mitral Valve DisorderMitral Valve InsufficiencyPremature calcification of mitral annulus

Where it's being run

43 sites across 22 states
Germany11
Italy5
France4
Canada2
Poland2
Switzerland2
United Kingdom2
Arizona1

Study leadership

  • Lenard Conradi, MD · PRINCIPAL_INVESTIGATOR · University of Cologne
  • Thomas Modine, MD · PRINCIPAL_INVESTIGATOR · University Hospital, Bordeaux
  • Sebastian Ludwig, MD · PRINCIPAL_INVESTIGATOR · University Heart and Vascular Center Hamburg, University Medical Center Hamburg-Eppendorf
  • Juan F Granada, MD · PRINCIPAL_INVESTIGATOR · Cardiovascular Research Foundation, New York, USA

Who to contact

Sebastian Ludwig, MD
[email protected]
+494074100
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

clinically significant mitral insufficiency
patient underwent screening for TMVI
echocardiography data at baseline (and after TMVI, E2E and surgery)
follow-up of at least 30 days

What this trial measures

  • Mitral insufficiency grade 2+ or more12 months

    Mitral insufficiency measured by transthoracic echocardiography. Assessment of MI severity according to current guidelines (ESC/EACTS and ACC/AHA) for valvular heart disease.

  • Freedom from device-related complications30 days