CHoice of OptImal transCatheter trEatment for Mitral Insufficiency Registry (CHOICE-MI)

Universitätsklinikum Hamburg-Eppendorf

Status: Enrolling

Conditions: Mitral Regurgitation

Study type: Observational

Funder types: Other

Identifiers

NCT04688190

CHOICE-MI

Details and patient eligibility

About

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.

Enrollment: 800 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

800 participants in 4 patient groups

Transcatheter Mitral Valve Implantation (TMVI)

Description:

Patients with successful TMVI screening, who underwent Transcatheter Mitral Valve Implantation subsequently. All devices may be included.

Interventional mitral valve edge-to-edge repair (E2E)

Description:

Patients with TMVI screening failure, who subsequently underwent interventional mitral valve edge-to-edge repair.

Mitral valve surgery (Surgery)

Description:

Patients with TMVI screening failure, who subsequently underwent mitral valve surgery (i.e., mitral valve repair or replacement).

Medical therapy (OMT)

Description:

Patients with TMVI screening failure, who subsequently underwent conservative or optimal medical therapy (OMT).