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Recruiting Not applicable

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

NCT04954404 · tracked via the Priya Life Science China tracker
Phase
Not applicable
Started
2021-05-01
Last updated
2021-07-08

Condition(s) studied

Mitral Valve Disease

Investigational drug(s) / intervention(s)

transcatheter mitral valve repair/transcatheter mitral valve replacement

transcatheter mitral valve repair/transcatheter mitral valve replacement: transcatheter mitral valve repair/transcatheter mitral valve replacement

Study summary

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

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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.

Primary outcome measure(s)

  • Composite outcomes of all-cause mortality and rate of rehospitalization related to heart failure. — 30 days, 6 months, 1 year, 2 years, 3 years, 5 years, 10 years
    Composite outcomes of all-cause mortality and rate of rehospitalization related to heart failure.

Trial sites (1)

FacilityCityRegionStatus
The Second Affiliated Hospital Zhejiang University School of Medicine. Hangzhou Zhejiang Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04954404 on ClinicalTrials.gov ↗ ← All trials in China