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NCT Number: NCT06911099

Assessment of Transcatheter Edge-to-Edge Repair in Atrial Functional Mitral Regurgitation (ATRIAL-MR)

This investigator-initiated, multicenter, international, retrospective registry aims to investigate outcomes of patients with atrial functional mitral regurgitation, as treated in clinical routine.

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Key information

Conditions

Atrial Functional Mitral Regurgitation Cardiovascular Diseases Heart Diseases Heart Valve Diseases Mitral Insufficiency Mitral Valve Insufficiency

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

St. Michael's Hospital, Toronto, Canada

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • functional mitral regurgitation
  • left ventricular ejection fraction ≥50%

Exclusion criteria

  • age under 18 years
  • known regional wall movement disorders

Treatment and study plan

Primary outcomes

  1. Composite of all-cause mortality and heart-failure related rehospitalitzation

    Time frame: 12 months

Secondary outcomes

  1. Residual Mitral Regurgitation ≤1+

    Time frame: 12 months

    Rate of patients achieving residual mitral regurgitation ≤1+ measured by transthoracic echocardiography. Assessment of mitral regurgitation severity according to current guidelines (ESC/EACTS and ACC/AHA) for valvular heart disease.

  2. All-cause mortality

    Time frame: 12 months

  3. Cardiovascular mortality

    Time frame: 12 months

  4. Heart failure related rehospitalization

    Time frame: 12 months

    Incidence of new-onset or worsening signs and symptoms of heart failure that required urgent therapy and resulted in hospitalization.

  5. Unplanned mitral valve intervention

    Time frame: 12 months

    Incidence of unplanned surgical or transcatheter re-intervention, heart transplantation or left ventricular assist device implantation.

  6. New York Heart Association (NYHA) class III or IV

    Time frame: 12 months

    Assessment of New York Heart Association (NYHA) classification stage (in- or outpatient), with the minimum of I (no symptoms) and the maximum of IV (dyspnea at rest), with higher values indicating worse functional capacity.

  7. 6 Minute Walking Distance

    Time frame: 12 months

Study contacts

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

Christos Iliadis, MD

CONTACT

[email protected]

+49-221-478-32401

Philipp von Stein, MD

CONTACT

[email protected]

646-321-8145

Sponsors and collaborators

Lead sponsor

University Hospital of Cologne

Other

Registry information

Official study title

Assessment of Transcatheter Edge-to-Edge Repair in Atrial Functional Mitral Regurgitation

Important dates

Study start
2010
Primary completion
2030
Study completion
2035
First posted
Apr 4, 2025
Registry last updated
Apr 6, 2025

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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