Transcatheter Mitral Valve InterventiOn Single Center Registry in CHinese Patients With Mitral Valve Disease (TORCH-M)

  • End date
    May 1, 2031
  • participants needed
  • sponsor
    Second Affiliated Hospital, School of Medicine, Zhejiang University
Updated on 15 July 2021


The purpose of this study is to evaluate the safety and effectiveness of transcatheter mitral valve intervention in Chinese population with mitral valve disease.


Prospective, single-arm, single-center clinical evaluation of transcatheter mitral valve intervention in subjects with mitral valve disease who are treated per standard of care and who have been determined by the local heart team as appropriate for interventional treatment. Eligible subjects will be treated by transcatheter mitral valve repair or transcatheter mitral valve replacement.

This single-arm registry will provide valuable new information regarding use of multiple mitral valve interventional devices and evaluate the safety and effectiveness of transcatheter mitral valve intervention in Chinese population with mitral valve disease.

Condition Mitral Valve Disease
Treatment transcatheter mitral valve repair/transcatheter mitral valve replacement
Clinical Study IdentifierNCT04954404
SponsorSecond Affiliated Hospital, School of Medicine, Zhejiang University
Last Modified on15 July 2021


Yes No Not Sure

Inclusion Criteria

Patients with mitral valve disease, as determined by the site from a transthoracic echocardiogram (TTE), and in the judgment of the investigator intervention is likely to provide clinical benefit for the patient
Subject has been informed of the nature of the study, agrees to its provisions and has provided written informed consent
The subject agrees to comply with specified follow-up evaluations and to return to the investigational site where the procedure was performed
Patients are technical and anatomical eligible for interventions

Exclusion Criteria

In the judgment of the investigator, subjects are not anatomical eligible for interventions
Known hypersensitivity or contraindication to procedural medications which cannot be adequately managed medically
Active endocarditis or active rheumatic heart disease
History of severe bleeding diathesis or coagulopathy or subject will refuse blood transfusions
Subject has any kind of conditions that might prevent patients benefiting from therapeutic benefit (i.e., Severe mental illness) or life expectancy is less than one year
Subject has any kind of disorder per investigator's judgement that compromises his/her ability to give written informed consent and/or to comply with study procedures
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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