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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorSecond Affiliated Hospital, School of Medicine, Zhejiang University

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 volunteers

Qualifiers

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

Design model

Single group

Treatments tested in this trial

  • transcatheter mitral valve repair/transcatheter mitral valve replacement

    Device

    transcatheter mitral valve repair/transcatheter mitral valve replacement

Treatment groups

2,000 Participants
are divided into 1 treatment group
Group A: Transcatheter mitral valve repair/replacementExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
30 days, 6 months, 1 year, 2 years, 3 years, 5 years, 10 years

Secondary outcomes

1

All-cause mortality

Death from any causes including both cardiovascular and non-cardiovascular.

Time frame
Predischarge, 30 days, 6 months, 1 year, 2 years, 3 years, 5 years, 10 years
2

Cardiovascular mortality

Death from any cardiovascular events.

Time frame
Predischarge, 30 days, 6 months, 1 year, 2 years, 3 years, 5 years, 10 years
3

Rehospitalization related to heart failure

Number of patients readmission for recurrent Heart Failure.

Time frame
30 days, 6 months, 1 year, 2 years, 3 years, 5 years, 10 years
4

Stroke

Time frame
Predischarge, 30 days, 6 months, 1 year, 2 years, 3 years, 5 years, 10 years

Other outcomes

Sponsors and contacts

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