Health TrialsbyHealthPanel

CHoice of OptImal transCatheter trEatment for Mitral Insufficiency Registry

ConditionsMitral RegurgitationMitral Valve DiseaseMitral Annular Calcification
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorUniversitätsklinikum Hamburg-Eppendorf

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

None

Trial population

This study aimes to include all patients with significant mitral insufficiency, who underwent screening for possible transcatheter mitral valve implantation (TMVI), irrespective of the subsequent therapy.

Trial design

Design model

Cohort

Time perspective

Retrospective

Treatments tested in this trial

Not listed

Trial groups

1,000 Participants
are grouped into 4 trial groups
Group A: Transcatheter Mitral Valve Replacement (TMVR)
Group B: Mitral transcatheter edge-to-edge repair (M-TEER)
Group C: Mitral valve surgery (Surgery)
Group D: Medical/conservative therapy

Trial outcomes

Primary outcomes

1

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.

Time frame
12 months
2

Freedom from device-related complications

Time frame
30 days

Secondary outcomes

1

Combined all-cause mortality or rehospitalization for congestive heart failure

Time frame
12 months
2

All-cause mortality

Time frame
12 months
3

Cardiovascular mortality

Time frame
12 months
4

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.

Time frame
12 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Universitätsklinikum Hamburg-Eppendorf

Lead sponsor

Montreal Heart Institute

Collaborator

University Hospital, Bordeaux

Collaborator

Source ClinicalTrials.gov
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