CHoice of OptImal transCatheter trEatment for Mitral Insufficiency Registry

NCT04688190 · tracked via the Priya Life Science Canada tracker

Sponsor

Universitätsklinikum Hamburg-Eppendorf

Phase

Observational

Started

2020-11-01

Last updated

2026-05-07

Condition(s) studied

Mitral RegurgitationMitral Valve DiseaseMitral Annular Calcification

Study summary

This multinational, investigator-initiated registry aims to investigate clinical outcomes of patients undergoing transcatheter mitral valve replacement (TMVR). The registry primarily focuses on patients treated with TMVR in real-world clinical practice.

Patients evaluated for TMVR but not undergoing the procedure are no longer systematically included. Historical data may include such patients who subsequently underwent alternative treatments, including transcatheter edge-to-edge repair, mitral valve surgery, or medical/conservative therapy.

Eligibility

Sex

ALL

Min age

18 Years

Max age

—

Healthy volunteers

Inclusion Criteria: * 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 Exclusion Criteria: \- age under 18 years

Primary outcome measure(s)

Mitral insufficiency grade 2+ or more — 12 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 complications — 30 days

Trial sites (43)

Facility	City	Region	Status
Tucson Medical Center	Tucson	Arizona	Recruiting
Cedars-Sinai Medical Center, Los Angeles	Los Angeles	California	Recruiting
Tampa General Hospital	Tampa	Florida	Recruiting
Brigham and Women's Hospital	Boston	Massachusetts	Recruiting
Minneapolis Heart Institute at Abbott Northwestern Hospital	Minneapolis	Minnesota	Recruiting
Morristown Medical Center	Morristown	New Jersey	Recruiting
Montefiore Medical Center	New York	New York	Recruiting
Oklahoma Heart Hospital	Oklahoma City	Oklahoma	Recruiting
Houston Methodist Hospital	Houston	Texas	Recruiting
St Vincent's Hospital	Sydney	Australia	Recruiting
Medical University of Vienna	Vienna	Austria	Recruiting
Québec Heart and Lung Institute (Laval University)	Québec	Quebec	Recruiting
Toronto Heart Center	Toronto	Canada	Recruiting
St. Paul's Hospital	Vancouver	Canada	Recruiting
Rigshospitalet	Copenhagen	Denmark	Recruiting
CHU Bordeaux	Bourdeaux	France	Recruiting
Lille University Hospital	Lille	France	Recruiting
Civils Hospices of Lyon	Lyon	France	Recruiting
Clinique Pasteur	Toulouse	France	Recruiting
HDZ Bad Oeynhausen	Bad Oeynhausen	Germany	Recruiting
German Heart Center Berlin	Berlin	Germany	Recruiting
Heart Center Bonn	Bonn	Germany	Recruiting
University Hospital of Cologne	Cologne	Germany	Recruiting
Goethe-Universität - University Hospital Frankfurt	Frankfurt	Germany	Recruiting
University Heart and Vascular Center Hamburg	Hamburg	Germany	Recruiting
University Heart Center Lübeck	Lübeck	Germany	Recruiting
Heart Center of the University Medical Center Mainz	Mainz	Germany	Recruiting
German Heart Centre Munich	Munich	Germany	Recruiting
LMU Munich	Munich	Germany	Recruiting
University Medical Center Ulm	Ulm	Germany	Recruiting
Interbalkan Medical Center	Thessaloniki	Greece	Recruiting
ASST Spedali Civili di Brescia	Brescia	Italy	Recruiting
San Raffaele University Hospital	Milan	Italy	Recruiting
IRCCS Humanitas Research Hospital	Milan	Italy	Recruiting
IRCCS Policlinico San Donato	Milan	Italy	Recruiting
University Hospital of Pisa	Pisa	Italy	Recruiting
Rikshospitalet, Oslo University Hospital (OUS)	Oslo	Norway	Recruiting
Poznan University of Medical Sciences	Poznan	Poland	Recruiting
Warsaw Medicover Hospital	Warsaw	Poland	Recruiting
Inselspital Bern	Bern	Switzerland	Recruiting

+ 3 more sites — see the full list on the official registry below.

More Universitätsklinikum Hamburg-Eppendorf trials in Canada

Spontaneous Coronary Artery Dissection - AntipLatelet Therapy Intensity in Guided coNservative Management (SCAD-ALIGN) Trial Starting soon

Other trials for the same condition

Clinical Trial to Evaluate the Safety and Effectiveness of Using the Tendyne Transcatheter Mitral Valve System for the Treatment of Symptomatic Mitral Regurgitation Active, not recruiting

ATLAS (AltaValve) Pivotal Trial Recruiting

Prospective Treatment Algorithm Guiding Repair of Severe Ischemic Mitral Regurgitation Active, not recruiting

Edwards PASCAL CLASP IID/IIF Pivotal Clinical Trial Active, not recruiting

The ENCIRCLE Trial Recruiting

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04688190 on ClinicalTrials.gov ↗ ← All trials in Canada