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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Mitral Valve Disease

Intervention / Treatment
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* Device: transcatheter mitral valve repair/transcatheter mitral valve replacement


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: Transcatheter mitral valve repair/Transcatheter mitral valve replacement
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Transcatheter mitral valve repair/replacement<br> | Device: transcatheter mitral valve repair/transcatheter mitral valve replacement<br>* transcatheter mitral valve repair/transcatheter mitral valve replacement<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 30 days, 6 months, 1 year, 2 years, 3 years, 5 years, 10 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| All-cause mortality | Death from any causes including both cardiovascular and non-cardiovascular. | Predischarge, 30 days, 6 months, 1 year, 2 years, 3 years, 5 years, 10 years | 
| Cardiovascular mortality | Death from any cardiovascular events. | Predischarge, 30 days, 6 months, 1 year, 2 years, 3 years, 5 years, 10 years | 
| Rehospitalization related to heart failure | Number of patients readmission for recurrent 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 | Number and volumes of new brain lesions detected by Magnetic Resonance Imaging (MRI) after procedure with or without clinical symptom. | Predischarge | 
| Myocardial infarction |  | Predischarge, 30 days, 6 months, 1 year, 2 years, 3 years, 5 years, 10 years | 
| Vascular complications |  | 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 | 
| Permanent pacemaker implantation |  | Predischarge, 30 days, 6 months, 1 year, 2 years, 3 years, 5 years, 10 years | 
| Device success | Defined according to consensus document from the mitral valve academic research consortium (MVARC). | Immediately after procedure | 
| Infective endocarditis | Number of patients with infective endocarditis. | Predischarge, 30 days, 6 months, 1 year, 2 years, 3 years, 5 years, 10 years | 
| Recurrent hospitalization - All cause | 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. | 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 | Change of NYHA status from baseline to each follow-up. | 30 days, 6 months, 1 year, 2 years, 3 years, 5 years, 10 years | 
| MR and/or MS severity | The change in MR and/or MS severity from baseline to each follow-up. | Predischarge, 30 days, 6 months, 1 year, 2 years, 3 years, 5 years, 10 years | 
| Quality of life improvement | Improvement in quality of life from baseline to each follow-up measured by the Kansas City Cardiomyopathy Questionnaire (KCCQ). | 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 | 
| Change of cognitive function | Change of cognitive function from baseline to each follow-up measured by the Mini-mental State Examination （MMSE）. | 30 days, 6 months, 1 year, 2 years, 3 years, 5 years, 10 years | 
| 6-min walk test | The change in 6-min walk test distance from baseline to each follow-up. | 30 days, 6 months, 1 year, 2 years, 3 years, 5 years, 10 years | 
| Reintervention of mitral valve | Any conditions need reintervention or surgery, as device-related thrombosis, valve deterioration. | Predischarge, 30 days, 6 months, 1 year, 2 years, 3 years, 5 years, 10 years | 
| Significant iatrogenic atrial septal defect | Number of patients reported as clinically significant iASD requiring ASD closure. | 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 | 
| Effective regurgitant orifice area |  | 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 | 
| Regurgitant fraction |  | 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 | 
| Mean mitral valve gradient |  | 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 | 
| 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 | 
| 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 | 
| BNP and/or NT-proBNP levels |  | Predischarge, 30 days, 6 months, 1 year, 2 years, 3 years, 5 years, 10 years |