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

Zhejiang University

Status: Enrolling

Conditions: Mitral Valve Disease

Treatments: Device: transcatheter mitral valve repair/transcatheter mitral valve replacement

Study type: Interventional

Funder types: Other

Identifiers

NCT04954404

2021-0593

Details and patient eligibility

About

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

Full description

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.

Enrollment: 2,000 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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2,000 participants in 1 patient group

Transcatheter mitral valve repair/replacement

Experimental group

Treatment:

Device: transcatheter mitral valve repair/transcatheter mitral valve replacement