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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

2000 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-05-01

Study Completion Date

2031-05-01

Brief Summary

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

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Detailed Description

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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.

Conditions

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Mitral Valve Disease

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Transcatheter mitral valve repair/Transcatheter mitral valve replacement

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Transcatheter mitral valve repair/replacement

Group Type EXPERIMENTAL

transcatheter mitral valve repair/transcatheter mitral valve replacement

Intervention Type DEVICE

transcatheter mitral valve repair/transcatheter mitral valve replacement

Interventions

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transcatheter mitral valve repair/transcatheter mitral valve replacement

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

1. 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.
2. Subject has been informed of the nature of the study, agrees to its provisions and has provided written informed consent.
3. The subject agrees to comply with specified follow-up evaluations and to return to the investigational site where the procedure was performed.
4. Patients are technical and anatomical eligible for interventions.

Exclusion Criteria

1. In the judgment of the investigator, subjects are not anatomical eligible for interventions.
2. Known hypersensitivity or contraindication to procedural medications which cannot be adequately managed medically.
3. Active endocarditis or active rheumatic heart disease.
4. History of severe bleeding diathesis or coagulopathy or subject will refuse blood transfusions.
5. 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.
6. 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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No