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NCT Number: NCT04688190

CHoice of OptImal transCatheter trEatment for Mitral Insufficiency Registry

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.

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Key information

Conditions

Mitral Regurgitation Cardiovascular Diseases Heart Diseases Heart Valve Diseases Mitral Annular Calcification Mitral Valve Disease Mitral Valve Insufficiency

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

St Vincent's Hospital, Sydney, Australia

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Mitral insufficiency grade 2+ or more

    Time frame: 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.

  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

    Time frame: 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.

  5. Combined cardiovascular mortality or rehospitalization for congestive heart failure

    Time frame: 12 months

  6. Unplanned mitral valve intervention

    Time frame: 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.

  7. Combined all-cause mortality, rehospitalization for congestive heart failure or unplanned mitral valve intervention

    Time frame: 12 months

  8. Combined cardiovascular mortality, rehospitalization for congestive heart failure or unplanned mitral valve intervention

    Time frame: 12 months

  9. New York Heart Association (NYHA) stage III or IV

    Time frame: 12 months

    Assessment of New York Heart Association (NYHA) classification stage (in- or outpatient) after 12 months follow-up, as assessed by patient interviews.

Study contacts

Contact information is provided by the study sponsor or research team.

Lena Strotmann, MD

CONTACT

[email protected]

+4074100

Sebastian Ludwig, MD

CONTACT

[email protected]

+494074100

Sponsors and collaborators

Lead sponsor

Universitätsklinikum Hamburg-Eppendorf

Other

Collaborators

  • Montreal Heart Institute
  • University Hospital, Bordeaux

Registry information

Acronym: CHOICE-MI

Important dates

Study start
2020
Primary completion
2030
Study completion
2030
First posted
Dec 29, 2020
Registry last updated
May 7, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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