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

Second Affiliated Hospital, School of Medicine, Zhejiang University1 site in 1 country2,000 target enrollmentMay 1, 2021

ConditionsMitral Valve Disease

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Mitral Valve Disease
Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University
Enrollment: 2000
Locations: 1
Primary Endpoint: Composite outcomes of all-cause mortality and rate of rehospitalization related to heart failure.
Status: Recruiting
Last Updated: 4 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief 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.

Detailed 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.

Registry

clinicaltrials.gov

Start Date

May 1, 2021

End Date

May 1, 2031

Last Updated

4 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Second Affiliated Hospital, School of Medicine, Zhejiang University

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•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 Criteria

•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.

Outcomes

Primary Outcomes

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

Composite outcomes of all-cause mortality and rate of rehospitalization related to heart failure.

Secondary Outcomes

Vascular complications(Predischarge, 30 days, 6 months, 1 year, 2 years, 3 years, 5 years, 10 years)
Quality of life improvement(30 days, 6 months, 1 year, 2 years, 3 years, 5 years, 10 years)
Change of cognitive function(30 days, 6 months, 1 year, 2 years, 3 years, 5 years, 10 years)
Significant iatrogenic atrial septal defect(Predischarge, 30 days, 6 months, 1 year, 2 years, 3 years, 5 years, 10 years)
Effective regurgitant orifice area(Predischarge, 30 days, 6 months, 1 year, 2 years, 3 years, 5 years, 10 years)
Mean mitral valve gradient(Predischarge, 30 days, 6 months, 1 year, 2 years, 3 years, 5 years, 10 years)
Rehospitalization related to heart failure(30 days, 6 months, 1 year, 2 years, 3 years, 5 years, 10 years)
Stroke(Predischarge, 30 days, 6 months, 1 year, 2 years, 3 years, 5 years, 10 years)
Transient ischemic attack(Predischarge, 30 days, 6 months, 1 year, 2 years, 3 years, 5 years, 10 years)
Brain lesion(Predischarge)
All-cause mortality(Predischarge, 30 days, 6 months, 1 year, 2 years, 3 years, 5 years, 10 years)
Cardiovascular mortality(Predischarge, 30 days, 6 months, 1 year, 2 years, 3 years, 5 years, 10 years)
Myocardial infarction(Predischarge, 30 days, 6 months, 1 year, 2 years, 3 years, 5 years, 10 years)
Permanent pacemaker implantation(Predischarge, 30 days, 6 months, 1 year, 2 years, 3 years, 5 years, 10 years)
Device success(Immediately after procedure)
Infective endocarditis(Predischarge, 30 days, 6 months, 1 year, 2 years, 3 years, 5 years, 10 years)
Bleeding events(Predischarge, 30 days, 6 months, 1 year, 2 years, 3 years, 5 years, 10 years)
Recurrent hospitalization - All cause(30 days, 6 months, 1 year, 2 years, 3 years, 5 years, 10 years)
Acute kidney injury(Predischarge, 30 days)
New-onset atrial fibrillation(Predischarge, 30 days, 6 months, 1 year, 2 years, 3 years, 5 years, 10 years)
Change of New York Heart Association functional classification(30 days, 6 months, 1 year, 2 years, 3 years, 5 years, 10 years)
MR and/or MS severity(Predischarge, 30 days, 6 months, 1 year, 2 years, 3 years, 5 years, 10 years)
Modified Rankin scale score(30 days, 6 months, 1 year, 2 years, 3 years, 5 years, 10 years)
6-min walk test(30 days, 6 months, 1 year, 2 years, 3 years, 5 years, 10 years)
Reintervention of mitral valve(Predischarge, 30 days, 6 months, 1 year, 2 years, 3 years, 5 years, 10 years)
Device embolization or single leaflet device attachment(Predischarge, 30 days, 6 months, 1 year, 2 years, 3 years, 5 years, 10 years)
Regurgitant fraction(Predischarge, 30 days, 6 months, 1 year, 2 years, 3 years, 5 years, 10 years)
Regurgitant volume(Predischarge, 30 days, 6 months, 1 year, 2 years, 3 years, 5 years, 10 years)
Mitral valve area(Predischarge, 30 days, 6 months, 1 year, 2 years, 3 years, 5 years, 10 years)
Left ventricular end-diastolic diameter (LVEDD)(Predischarge, 30 days, 6 months, 1 year, 2 years, 3 years, 5 years, 10 years)
Left ventricular end-systolic diameter (LVESD)(Predischarge, 30 days, 6 months, 1 year, 2 years, 3 years, 5 years, 10 years)
BNP and/or NT-proBNP levels(Predischarge, 30 days, 6 months, 1 year, 2 years, 3 years, 5 years, 10 years)
Left ventricular ejection fraction (LVEF)(Predischarge, 30 days, 6 months, 1 year, 2 years, 3 years, 5 years, 10 years)
Pulmonary artery systolic pressure (PASP)(Predischarge, 30 days, 6 months, 1 year, 2 years, 3 years, 5 years, 10 years)
Right ventricular systolic pressure (RVSP)(Predischarge, 30 days, 6 months, 1 year, 2 years, 3 years, 5 years, 10 years)
Left ventricular mass(Predischarge, 30 days, 6 months, 1 year, 2 years, 3 years, 5 years, 10 years)