CHoice of OptImal transCatheter trEatment for Mitral Insufficiency Registry

Conditions

Mitral Annular Calcification, Mitral Regurgitation, Mitral Valve Disease

Brief 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.

Sebastian Ludwig, Augustin Coisne, Kenza Hamzi, Walid Ben Ali, Andrea Scotti et al. (80 authors)

European Heart Journal - Cardiovascular Imaging2025-05-072 citations

10.1093/ehjci/jeaf141

Outcomes Following Transcatheter Mitral Valve Replacement Using Dedicated Devices in Patients With Mitral Annular Calcification.

Coisne A, Ludwig S, Scotti A, Ben Ali W, Weimann J, Duncan A, Webb JG, Kalbacher D, Rudolph TK, Nickenig G, Hausleiter J, Ruge H, Adam M, Petronio AS, Dumonteil N, Søndergaard L, Adamo M, Regazzoli D, Garatti A, Schmidt T, Dahle G, Taramasso M, Walther T, Kempfert J, Obadia JF, Redwood S, Tang GHL, Goel S, Fam N, Metra M, Andreas M, Muller DW, Denti P, Praz F, von Bardeleben RS, Leroux L, Latib A, Granada JF, Conradi L, Modine T, CHOICE-MI Investigators.

2024-09-0410 citations

10.1016/j.jcin.2024.07.038

Transcatheter Mitral Valve Replacement Versus Medical Therapy for Secondary Mitral Regurgitation: A Propensity Score–Matched Comparison

Sebastian Ludwig, Lenard Conradi, David J. Cohen, Augustin Coisne, Andrea Scotti et al. (49 authors)

Circulation Cardiovascular Interventions2023-05-1717 citations

10.1161/circinterventions.123.013045

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

No

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

Design outcomes

Primary

Measure	Time frame	Description
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	—

Secondary

Measure	Time frame	Description
Combined all-cause mortality or rehospitalization for congestive heart failure	12 months	—
All-cause mortality	12 months	—
Cardiovascular mortality	12 months	—
Rehospitalization for congestive heart failure	12 months	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.
Combined cardiovascular mortality or rehospitalization for congestive heart failure	12 months	—
Unplanned mitral valve intervention	12 months	Incidence of unplanned surgical or transcatheter re-intervention, heart transplantation or left ventricular assist device implantation, e.g. as assessed by patient interviews.
Combined all-cause mortality, rehospitalization for congestive heart failure or unplanned mitral valve intervention	12 months	—
Combined cardiovascular mortality, rehospitalization for congestive heart failure or unplanned mitral valve intervention	12 months	—
New York Heart Association (NYHA) stage III or IV	12 months	Assessment of New York Heart Association (NYHA) classification stage (in- or outpatient) after 12 months follow-up, as assessed by patient interviews.

Countries

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

Contacts

CONTACTSebastian Ludwig, MD

se.ludwig@uke.de+494074100

CONTACTLena Strotmann, MD

L.Strotmann@uke.de+4074100

PRINCIPAL_INVESTIGATORLenard Conradi, MD

University of Cologne

PRINCIPAL_INVESTIGATORThomas Modine, MD

University Hospital, Bordeaux

PRINCIPAL_INVESTIGATORSebastian Ludwig, MD

University Heart and Vascular Center Hamburg, University Medical Center Hamburg-Eppendorf

PRINCIPAL_INVESTIGATORJuan F Granada, MD

Cardiovascular Research Foundation, New York, USA

Outcome results