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

Choice of Optimal Transcatheter Treatment for Mitral Insufficiency Registry

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.

Study Overview

• Status: Recruiting
• Conditions: Mitral Regurgitation

• Study Type: Observational
• Enrollment (Anticipated): 800

Contacts and Locations

• Study Contact: Name: Sebastian Ludwig, MD; Phone Number: +4915222816168; Email: se.ludwig@uke.de
• Study Contact Backup: Name: Walid Ben Ali, MD; Phone Number: +15145611037; Email: dr.walidbenali@gmail.com

Study Locations

• Australia
  • Sydney, Australia
    • Recruiting
    • St Vincent's Hospital
    • Contact: David Muller, MD
• Canada
  • Toronto, Canada
    • Recruiting
    • Toronto Heart Center
  • Vancouver, Canada
    • Recruiting
    • St. Paul's Hospital
    • Contact: John G Webb, MD
• Denmark
  • Copenhagen, Denmark
    • Recruiting
    • Rigshospitalet
    • Contact: Lars Sondergaard, MD
• France
  • Bourdeaux, France
    • Recruiting
    • CHU Bordeaux
    • Contact: Thomas Modine, MD
  • Lille, France
    • Recruiting
    • Lille University Hospital
    • Contact: Augustin Coisne, MD
  • Lyon, France
    • Recruiting
    • Civils Hospices of Lyon
    • Contact: Jean-François Obadia, MD
  • Toulouse, France
    • Recruiting
    • Clinique Pasteur
    • Contact: Nicolas Dumonteil, MD
• Germany
  • Bad Oeynhausen, Germany
    • Recruiting
    • HDZ Bad Oeynhausen
    • Contact: Tanja Rudolph, MD
    • Contact: Sabine Bleiziffer, MD
  • Berlin, Germany
    • Recruiting
    • German Heart Center Berlin
    • Contact: Jörg Kempfert, MD
    • Contact: Axel Unbehaun, MD
  • Bonn, Germany
    • Recruiting
    • Heart Center Bonn
    • Contact: Marcel Weber, MD
  • Cologne, Germany
    • Recruiting
    • University Hospital of Cologne
    • Contact: Matti Adam, MD
  • Frankfurt, Germany
    • Recruiting
    • Goethe-Universität - University Hospital Frankfurt
    • Contact: Thomas Walther, MD
  • Hamburg, Germany
    • Recruiting
    • University Heart and Vascular Center Hamburg
    • Principal Investigator: Lenard Conradi, MD
  • Mainz, Germany
    • Recruiting
    • Heart Center of the University Medical Center Mainz
    • Contact: Ralph Stephan von Bardeleben, MD
    • Contact: Felix Kreidel, MD
  • Munich, Germany
    • Recruiting
    • German Heart Centre Munich
    • Contact: Hendrik Ruge, MD
    • Contact: Rüdiger Lange, MD
  • Munich, Germany
    • Recruiting
    • LMU Munich
    • Contact: Jörg Hausleiter, MD
• Italy
  • Milan, Italy
    • Recruiting
    • San Raffaele University Hospital
    • Contact: Paolo Denti, MD
• Norway
  • Oslo, Norway
    • Recruiting
    • Rikshospitalet, Oslo University Hospital (OUS)
    • Contact: Gry Dahle, MD
• Switzerland
  • Bern, Switzerland
    • Recruiting
    • Inselspital Bern
    • Contact: Fabien Praz, MD
    • Contact: Mirjam Wild, MD
  • Zürich, Switzerland
    • Recruiting
    • USZ Zurich
    • Contact: Alberto Pozzoli, MD
    • Contact: Maurizio Taramasso, MD
• United Kingdom
  • London, United Kingdom
    • Recruiting
    • Royal Brompton Hospital
    • Contact: Alison Duncan, MD
  • London, United Kingdom
    • Recruiting
    • St Thomas' Hospital - London
    • Contact: Simon Redwood, MD
    • Contact: Omar Chehab, MD
• United States
  • California
    • Los Angeles, California, United States, 90048
      • Recruiting
      • Cedars-Sinai Medical Center, Los Angeles
      • Contact: Raj Makkar, MD
      • Contact: Sung-Han Yoon, MD
  • Massachusetts
    • Boston, Massachusetts, United States, 02115
      • Recruiting
      • Brigham and Women's Hospital
      • Contact: Tsuyoshi Kaneko, MD
      • Contact: Pinak Shah, MD
  • Texas
    • Houston, Texas, United States, 77030
      • Recruiting
      • Houston Methodist Hospital
      • Contact: Michael Reardon, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study 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.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

4

Cohorts and Interventions

Group / Cohort
Transcatheter Mitral Valve Implantation (TMVI); 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); Patients with TMVI screening failure, who subsequently underwent interventional mitral valve edge-to-edge repair.
Mitral valve surgery (Surgery); Patients with TMVI screening failure, who subsequently underwent mitral valve surgery (i.e., mitral valve repair or replacement).
Medical therapy (OMT); Patients with TMVI screening failure, who subsequently underwent conservative or optimal medical therapy (OMT).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Freedom from device-related complications		30 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
All-cause mortality		12 months
Cardiovascular mortality		12 months
Combined all-cause mortality or rehospitalization for congestive heart failure		12 months
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
Combined cardiovascular mortality or rehospitalization for congestive heart failure		12 months
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
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	Assessment of New York Heart Association (NYHA) classification stage (in- or outpatient) after 12 months follow-up, as assessed by patient interviews.	12 months

Collaborators and Investigators

• Sponsor: Universitätsklinikum Hamburg-Eppendorf
• Collaborators: University Hospital, Bordeaux; Montreal Heart Institute
• Investigators: Principal Investigator: Lenard Conradi, MD, University Heart and Vascular Center Hamburg; Principal Investigator: Thomas Modine, MD, University Hospital, Bordeaux; Principal Investigator: Walid Ben Ali, MD, Montreal Heart Institute; Principal Investigator: Alison Duncan, MD, Royal Brompton Hospital London; Principal Investigator: Gilbert Tang, MD, Mount Sinai Medical Center, NYC; Principal Investigator: Juan F Granada, MD, Cardiovascular Research Foundation, New York, USA

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2020
• Primary Completion (Anticipated): March 1, 2025
• Study Completion (Anticipated): December 31, 2030

Study Registration Dates

• First Submitted: December 18, 2020
• First Submitted That Met QC Criteria: December 25, 2020
• First Posted (Actual): December 29, 2020

Study Record Updates

• Last Update Posted (Actual): May 17, 2022
• Last Update Submitted That Met QC Criteria: May 16, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Heart Valve Diseases; Mitral Valve Insufficiency
• Other Study ID Numbers: CHOICE-MI

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No