Transcatheter Mitral Valve InterventiOn Single Center Registry in CHinese Patients With Mitral Valve Disease (TORCH-M)
- Conditions
- Mitral Valve Disease
- Interventions
- Device: transcatheter mitral valve repair/transcatheter mitral valve replacement
- Registration Number
- NCT04954404
- Lead Sponsor
- Second Affiliated Hospital, School of Medicine, Zhejiang University
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 2000
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Transcatheter mitral valve repair/replacement transcatheter mitral valve repair/transcatheter mitral valve replacement -
- Primary Outcome Measures
Name Time Method Composite outcomes of all-cause mortality and rate of rehospitalization related to heart failure. 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 Outcome Measures
Name Time Method 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 Improvement in quality of life from baseline to each follow-up measured by the Kansas City Cardiomyopathy Questionnaire (KCCQ).
Change of cognitive function 30 days, 6 months, 1 year, 2 years, 3 years, 5 years, 10 years Change of cognitive function from baseline to each follow-up measured by the Mini-mental State Examination （MMSE）.
Significant iatrogenic atrial septal defect Predischarge, 30 days, 6 months, 1 year, 2 years, 3 years, 5 years, 10 years Number of patients reported as clinically significant iASD requiring ASD closure.
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 Number of patients readmission for recurrent Heart Failure.
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 Number and volumes of new brain lesions detected by Magnetic Resonance Imaging (MRI) after procedure with or without clinical symptom.
All-cause mortality Predischarge, 30 days, 6 months, 1 year, 2 years, 3 years, 5 years, 10 years Death from any causes including both cardiovascular and non-cardiovascular.
Cardiovascular mortality Predischarge, 30 days, 6 months, 1 year, 2 years, 3 years, 5 years, 10 years Death from any cardiovascular events.
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 Defined according to consensus document from the mitral valve academic research consortium (MVARC).
Infective endocarditis Predischarge, 30 days, 6 months, 1 year, 2 years, 3 years, 5 years, 10 years Number of patients with infective endocarditis.
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 Number of patients hospitalized for≥24h. Hospitalizations planned for pre-existing conditions are excluded unless there is worsening of the baseline condition according to MVARC.
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 Change of NYHA status from baseline to each follow-up.
MR and/or MS severity Predischarge, 30 days, 6 months, 1 year, 2 years, 3 years, 5 years, 10 years The change in MR and/or MS severity from baseline to each follow-up.
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 The change in 6-min walk test distance from baseline to each follow-up.
Reintervention of mitral valve Predischarge, 30 days, 6 months, 1 year, 2 years, 3 years, 5 years, 10 years Any conditions need reintervention or surgery, as device-related thrombosis, valve deterioration.
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
Trial Locations
- Locations (1)
The Second Affiliated Hospital Zhejiang University School of Medicine.
🇨🇳Hangzhou, Zhejiang, China