About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Single group
Treatments tested in this trial
transcatheter mitral valve repair/transcatheter mitral valve replacement
Devicetranscatheter mitral valve repair/transcatheter mitral valve replacement
Treatment groups
Trial outcomes
Primary outcomes
Composite outcomes of all-cause mortality and rate of rehospitalization related to heart failure.
Composite outcomes of all-cause mortality and rate of rehospitalization related to heart failure.
Secondary outcomes
All-cause mortality
Death from any causes including both cardiovascular and non-cardiovascular.
Cardiovascular mortality
Death from any cardiovascular events.
Rehospitalization related to heart failure
Number of patients readmission for recurrent Heart Failure.
Stroke
Sponsors and contacts
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