CHoice of OptImal transCatheter trEatment for Mitral Insufficiency Registry

Mitral Regurgitation Clinical Trial

— CHOICE-MI  

Official title:

Choice of Optimal Transcatheter Treatment for Mitral Insufficiency Registry

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04688190
• Other study ID #: CHOICE-MI
• Status: Recruiting
• Start date: November 1, 2020
• Est. completion date: December 31, 2030

Study information

• Verified date: May 2022
• Source: Universitätsklinikum Hamburg-Eppendorf
• Contact: Sebastian Ludwig, MD
• Phone: +4915222816168
• Email: se.ludwig[@]uke.de
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

This multinational, investigator-initiated, retrospective study aims to investigate outcomes of patients, who underwent transcatheter mitral valve implantation (TMVI), in comparison to those screened for TMVI but deemed ineligible, who subsequently underwent interventional mitral valve edge-to-edge repair, mitral valve surgery or medical/conservative therapy.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 800
• Est. completion date: December 31, 2030
• Est. primary completion date: March 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Mitral Regurgitation
• Mitral Valve Insufficiency

Locations

Country	Name	City	State
Australia	St Vincent's Hospital	Sydney
Canada	Toronto Heart Center	Toronto
Canada	St. Paul's Hospital	Vancouver
Denmark	Rigshospitalet	Copenhagen
France	CHU Bordeaux	Bourdeaux
France	Lille University Hospital	Lille
France	Civils Hospices of Lyon	Lyon
France	Clinique Pasteur	Toulouse
Germany	HDZ Bad Oeynhausen	Bad Oeynhausen
Germany	German Heart Center Berlin	Berlin
Germany	Heart Center Bonn	Bonn
Germany	University Hospital of Cologne	Cologne
Germany	Goethe-Universität - University Hospital Frankfurt	Frankfurt
Germany	University Heart and Vascular Center Hamburg	Hamburg
Germany	Heart Center of the University Medical Center Mainz	Mainz
Germany	German Heart Centre Munich	Munich
Germany	LMU Munich	Munich
Italy	San Raffaele University Hospital	Milan
Norway	Rikshospitalet, Oslo University Hospital (OUS)	Oslo
Switzerland	Inselspital Bern	Bern
Switzerland	USZ Zurich	Zürich
United Kingdom	Royal Brompton Hospital	London
United Kingdom	St Thomas' Hospital - London	London
United States	Brigham and Women's Hospital	Boston	Massachusetts
United States	Houston Methodist Hospital	Houston	Texas
United States	Cedars-Sinai Medical Center, Los Angeles	Los Angeles	California

Sponsors (3)

Lead Sponsor	Collaborator
Universitätsklinikum Hamburg-Eppendorf	Montreal Heart Institute, University Hospital, Bordeaux

Countries where clinical trial is conducted

United States,  Australia,  Canada,  Denmark,  France,  Germany,  Italy,  Norway,  Switzerland,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mitral insufficiency grade 2+ or more	Mitral insufficiency measured by transthoracic echocardiography. Assessment of MI severity according to current guidelines (ESC/EACTS and ACC/AHA) for valvular heart disease.	12 months
Primary	Freedom from device-related complications		30 days
Secondary	Combined all-cause mortality or rehospitalization for congestive heart failure		12 months
Secondary	All-cause mortality		12 months
Secondary	Cardiovascular mortality		12 months
Secondary	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.	12 months
Secondary	Combined cardiovascular mortality or rehospitalization for congestive heart failure		12 months
Secondary	Unplanned mitral valve intervention	Incidence of unplanned surgical or transcatheter re-intervention, heart transplantation or left ventricular assist device implantation, e.g. as assessed by patient interviews.	12 months
Secondary	Combined all-cause mortality, rehospitalization for congestive heart failure or unplanned mitral valve intervention		12 months
Secondary	Combined cardiovascular mortality, rehospitalization for congestive heart failure or unplanned mitral valve intervention		12 months
Secondary	New York Heart Association (NYHA) stage III or IV	Assessment of New York Heart Association (NYHA) classification stage (in- or outpatient) after 12 months follow-up, as assessed by patient interviews.	12 months