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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Transcatheter mitral valve repair/replacement | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| transcatheter mitral valve repair/transcatheter mitral valve replacement | Device | transcatheter mitral valve repair/transcatheter mitral valve replacement |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jian'an Wang, PhD, MD | Contact | +86057187783777 | wja@zju.edu.cn |
| Name | Affiliation | Role |
|---|---|---|
| Jian'an Wang, PhD, MD | 2nd Affiliated Hospital, School of Medicine, Zhejiang University, China | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Second Affiliated Hospital Zhejiang University School of Medicine. | Recruiting | Hangzhou | Zhejiang | 310006 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39049480 | Derived | Pu Z, Yu T, Liu X, Lin X, Li H, Lim DS, Wang J. A modified Carpentier classification in transcatheter edge-to-edge repair for mitral regurgitation. Catheter Cardiovasc Interv. 2024 Oct;104(4):870-877. doi: 10.1002/ccd.31158. Epub 2024 Jul 24. |
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Transcatheter mitral valve repair/Transcatheter mitral valve replacement
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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 |