Mitral Valve Disease
Conditions
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.
Interventions
DEVICEtranscatheter mitral valve repair/transcatheter mitral valve replacement
transcatheter mitral valve repair/transcatheter mitral valve replacement
Sponsors
Second Affiliated Hospital, School of Medicine, Zhejiang University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Transcatheter mitral valve repair/Transcatheter mitral valve replacement
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Cardiovascular mortality | Predischarge, 30 days, 6 months, 1 year, 2 years, 3 years, 5 years, 10 years | Death from any cardiovascular events. |
| 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. |
| 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 | 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. |
| 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. |
| 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). |
| 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. |
| 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）. |
| 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. |
| 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. |
| 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 | — |
| Modified Rankin scale score | 30 days, 6 months, 1 year, 2 years, 3 years, 5 years, 10 years | — |
Countries
China
Contacts
Primary ContactJian'an Wang, PhD, MD
Outcome results
None listed