RecruitingNot ApplicableNCT04954404

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

Sponsor

Second Affiliated Hospital, School of Medicine, Zhejiang University

Enrollment

2,000 participants

Start Date

May 1, 2021

Study Type

INTERVENTIONAL

Conditions

Mitral Valve Disease

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

Min Age: 18 Years

Inclusion Criteria4

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 Criteria6

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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Interventions

DEVICEtranscatheter mitral valve repair/transcatheter mitral valve replacement

transcatheter mitral valve repair/transcatheter mitral valve replacement

Locations(1)

The Second Affiliated Hospital Zhejiang University School of Medicine.

Hangzhou, Zhejiang, China

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