Clinical trial NCT04954404: Transcatheter Mitral Valve InterventiOn Single Center Registry in CHinese Patients With Mitral Valve Disease (TORCH-M)
Official title: Transcatheter Mitral Valve InterventiOn Single Center Registry in CHinese Patients With Mitral Valve Disease (TORCH-M)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Mitral Valve Disease
Lead sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University
Sponsor class: OTHER
First posted: 2021-07-08
Enrollment: 2000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Transcatheter mitral valve repair/Transcatheter mitral valve replacement
Primary purpose: TREATMENT

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.

Eligibility criteria: 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 outcomes:
measure: Composite outcomes of all-cause mortality and rate of rehospitalization related to heart failure.
timeFrame: 30 days, 6 months, 1 year, 2 years, 3 years, 5 years, 10 years
Secondary outcomes:
measure: All-cause mortality
timeFrame: Predischarge, 30 days, 6 months, 1 year, 2 years, 3 years, 5 years, 10 years
measure: Cardiovascular mortality
timeFrame: Predischarge, 30 days, 6 months, 1 year, 2 years, 3 years, 5 years, 10 years
measure: Rehospitalization related to heart failure
timeFrame: 30 days, 6 months, 1 year, 2 years, 3 years, 5 years, 10 years
measure: Stroke
timeFrame: Predischarge, 30 days, 6 months, 1 year, 2 years, 3 years, 5 years, 10 years
measure: Transient ischemic attack
timeFrame: Predischarge, 30 days, 6 months, 1 year, 2 years, 3 years, 5 years, 10 years
measure: Brain lesion
timeFrame: Predischarge
measure: Myocardial infarction
timeFrame: Predischarge, 30 days, 6 months, 1 year, 2 years, 3 years, 5 years, 10 years
measure: Vascular complications
timeFrame: Predischarge, 30 days, 6 months, 1 year, 2 years, 3 years, 5 years, 10 years
measure: Bleeding events
timeFrame: Predischarge, 30 days, 6 months, 1 year, 2 years, 3 years, 5 years, 10 years
measure: Permanent pacemaker implantation
timeFrame: Predischarge, 30 days, 6 months, 1 year, 2 years, 3 years, 5 years, 10 years
measure: Device success
timeFrame: Immediately after procedure
measure: Infective endocarditis
timeFrame: Predischarge, 30 days, 6 months, 1 year, 2 years, 3 years, 5 years, 10 years
measure: Recurrent hospitalization - All cause
timeFrame: 30 days, 6 months, 1 year, 2 years, 3 years, 5 years, 10 years
measure: Acute kidney injury
timeFrame: Predischarge, 30 days
measure: New-onset atrial fibrillation
timeFrame: Predischarge, 30 days, 6 months, 1 year, 2 years, 3 years, 5 years, 10 years
measure: Change of New York Heart Association functional classification
timeFrame: 30 days, 6 months, 1 year, 2 years, 3 years, 5 years, 10 years
measure: MR and/or MS severity
timeFrame: Predischarge, 30 days, 6 months, 1 year, 2 years, 3 years, 5 years, 10 years
measure: Quality of life improvement
timeFrame: 30 days, 6 months, 1 year, 2 years, 3 years, 5 years, 10 years
measure: Modified Rankin scale score
timeFrame: 30 days, 6 months, 1 year, 2 years, 3 years, 5 years, 10 years
measure: Change of cognitive function
timeFrame: 30 days, 6 months, 1 year, 2 years, 3 years, 5 years, 10 years
measure: 6-min walk test
timeFrame: 30 days, 6 months, 1 year, 2 years, 3 years, 5 years, 10 years
measure: Reintervention of mitral valve
timeFrame: Predischarge, 30 days, 6 months, 1 year, 2 years, 3 years, 5 years, 10 years
measure: Significant iatrogenic atrial septal defect
timeFrame: Predischarge, 30 days, 6 months, 1 year, 2 years, 3 years, 5 years, 10 years
measure: Device embolization or single leaflet device attachment
timeFrame: Predischarge, 30 days, 6 months, 1 year, 2 years, 3 years, 5 years, 10 years
measure: Effective regurgitant orifice area
timeFrame: Predischarge, 30 days, 6 months, 1 year, 2 years, 3 years, 5 years, 10 years
measure: Regurgitant volume
timeFrame: Predischarge, 30 days, 6 months, 1 year, 2 years, 3 years, 5 years, 10 years
measure: Regurgitant fraction
timeFrame: Predischarge, 30 days, 6 months, 1 year, 2 years, 3 years, 5 years, 10 years
measure: Mitral valve area
timeFrame: Predischarge, 30 days, 6 months, 1 year, 2 years, 3 years, 5 years, 10 years
measure: Mean mitral valve gradient
timeFrame: Predischarge, 30 days, 6 months, 1 year, 2 years, 3 years, 5 years, 10 years
measure: Left ventricular ejection fraction (LVEF)
timeFrame: Predischarge, 30 days, 6 months, 1 year, 2 years, 3 years, 5 years, 10 years
measure: Left ventricular end-diastolic diameter (LVEDD)
timeFrame: Predischarge, 30 days, 6 months, 1 year, 2 years, 3 years, 5 years, 10 years
measure: Left ventricular end-systolic diameter (LVESD)
timeFrame: Predischarge, 30 days, 6 months, 1 year, 2 years, 3 years, 5 years, 10 years
measure: Pulmonary artery systolic pressure (PASP)
timeFrame: Predischarge, 30 days, 6 months, 1 year, 2 years, 3 years, 5 years, 10 years
measure: Right ventricular systolic pressure (RVSP)
timeFrame: Predischarge, 30 days, 6 months, 1 year, 2 years, 3 years, 5 years, 10 years
measure: Left ventricular mass
timeFrame: Predischarge, 30 days, 6 months, 1 year, 2 years, 3 years, 5 years, 10 years
measure: BNP and/or NT-proBNP levels
timeFrame: Predischarge, 30 days, 6 months, 1 year, 2 years, 3 years, 5 years, 10 years
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: The Second Affiliated Hospital Zhejiang University School of Medicine.
state: Zhejiang
Study officials:
affiliation: 2nd Affiliated Hospital, School of Medicine, Zhejiang University, China
name: Jian'an Wang, PhD, MD
role: STUDY_CHAIR
References: