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Recruiting NCT04688190

CHoice of OptImal transCatheter trEatment for Mitral Insufficiency Registry

— Observational Mitral Regurgitation Mitral Valve Disease Mitral Annular Calcification

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Mitral Regurgitation, Mitral Valve Disease, Mitral Annular Calcification. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States, Australia, Austria, Canada, Denmark +8
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Choice of Optimal Transcatheter Treatment for Mitral Insufficiency Registry

Overview

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.

Primary outcome measures

  • Mitral insufficiency grade 2+ or more [Time frame: 12 months]
  • Freedom from device-related complications [Time frame: 30 days]
Secondary outcome measures (9)
  • Combined all-cause mortality or rehospitalization for congestive heart failure [Time frame: 12 months]
  • All-cause mortality [Time frame: 12 months]
  • Cardiovascular mortality [Time frame: 12 months]
  • Rehospitalization for congestive heart failure [Time frame: 12 months]
  • Combined cardiovascular mortality or rehospitalization for congestive heart failure [Time frame: 12 months]
  • Unplanned mitral valve intervention [Time frame: 12 months]
  • Combined all-cause mortality, rehospitalization for congestive heart failure or unplanned mitral valve intervention [Time frame: 12 months]
  • Combined cardiovascular mortality, rehospitalization for congestive heart failure or unplanned mitral valve intervention [Time frame: 12 months]
  • New York Heart Association (NYHA) stage III or IV [Time frame: 12 months]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

Germany · 11 centers
  • HDZ Bad Oeynhausen — Bad Oeynhausen
  • German Heart Center Berlin — Berlin
  • Heart Center Bonn — Bonn
  • University Hospital of Cologne — Cologne
  • Goethe-Universität - University Hospital Frankfurt — Frankfurt
  • University Heart and Vascular Center Hamburg — Hamburg
  • University Heart Center Lübeck — Lübeck
  • Heart Center of the University Medical Center Mainz — Mainz
  • … and 3 more centers
United States · 9 centers
  • Tucson Medical Center — Tucson
  • Cedars-Sinai Medical Center, Los Angeles — Los Angeles
  • Tampa General Hospital — Tampa
  • Brigham and Women's Hospital — Boston
  • Minneapolis Heart Institute at Abbott Northwestern Hospital — Minneapolis
  • Morristown Medical Center — Morristown
  • Montefiore Medical Center — New York
  • Oklahoma Heart Hospital — Oklahoma City
  • … and 1 more center
Italy · 5 centers
  • ASST Spedali Civili di Brescia — Brescia
  • San Raffaele University Hospital — Milan
  • IRCCS Humanitas Research Hospital — Milan
  • IRCCS Policlinico San Donato — Milan
  • University Hospital of Pisa — Pisa
France · 4 centers
  • CHU Bordeaux — Bourdeaux
  • Lille University Hospital — Lille
  • Civils Hospices of Lyon — Lyon
  • Clinique Pasteur — Toulouse
Canada · 3 centers
  • Québec Heart and Lung Institute (Laval University) — Québec
  • Toronto Heart Center — Toronto
  • St. Paul's Hospital — Vancouver
Poland · 2 centers
  • Poznan University of Medical Sciences — Poznan
  • Warsaw Medicover Hospital — Warsaw
Switzerland · 2 centers
  • Inselspital Bern — Bern
  • USZ Zurich — Zurich
United Kingdom · 2 centers
  • Royal Brompton Hospital — London
  • St Thomas' Hospital - London — London
Australia · 1 center
  • St Vincent's Hospital — Sydney
Austria · 1 center
  • Medical University of Vienna — Vienna
Denmark · 1 center
  • Rigshospitalet — Copenhagen
Greece · 1 center
  • Interbalkan Medical Center — Thessaloniki
Norway · 1 center
  • Rikshospitalet, Oslo University Hospital (OUS) — Oslo

Publications

  • Ludwig S, Coisne A, Hamzi K, Ben Ali W, Scotti A, Koell B, Duncan A, Makkar R, Akodad M, Bleiziffer S, Nickenig G, Kaneko T, Ruge H, Adam M, Sondergaard L, Dahle G, Taramasso M, Walther T, Kempfert J, Obadia JF, Chehab O, Tang GHL, Goel S, Fam N, Denti P, Praz F, von Bardeleben RS, Hausleiter J, Latib A, Conradi L, Modine T, Pezel T, Granada JF; CHOICE-MI Investigators. Phenotypic clustering analy PMID 40329826
  • 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, Sondergaard 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, PMID 39243262
  • Ludwig S, Conradi L, Cohen DJ, Coisne A, Scotti A, Abraham WT, Ben Ali W, Zhou Z, Li Y, Kar S, Duncan A, Lim DS, Adamo M, Redfors B, Muller DWM, Webb JG, Petronio AS, Ruge H, Nickenig G, Sondergaard L, Adam M, Regazzoli D, Garatti A, Schmidt T, Andreas M, Dahle G, Walther T, Kempfert J, Tang GHL, Redwood S, Taramasso M, Praz F, Fam N, Dumonteil N, Obadia JF, von Bardeleben RS, Rudolph TK, Reardon PMID 37194288

Identifiers

NCT: NCT04688190 · CHOICE-MI

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗