Outcome
Type |
Measure |
Description |
Time frame |
Safety issue |
Primary |
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 |
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 |
|
Secondary |
Cardiovascular mortality |
Death from any cardiovascular events. |
Predischarge, 30 days, 6 months, 1 year, 2 years, 3 years, 5 years, 10 years |
|
Secondary |
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 |
|
Secondary |
Stroke |
|
Predischarge, 30 days, 6 months, 1 year, 2 years, 3 years, 5 years, 10 years |
|
Secondary |
Transient ischemic attack |
|
Predischarge, 30 days, 6 months, 1 year, 2 years, 3 years, 5 years, 10 years |
|
Secondary |
Brain lesion |
Number and volumes of new brain lesions detected by Magnetic Resonance Imaging (MRI) after procedure with or without clinical symptom. |
Predischarge |
|
Secondary |
Myocardial infarction |
|
Predischarge, 30 days, 6 months, 1 year, 2 years, 3 years, 5 years, 10 years |
|
Secondary |
Vascular complications |
|
Predischarge, 30 days, 6 months, 1 year, 2 years, 3 years, 5 years, 10 years |
|
Secondary |
Bleeding events |
|
Predischarge, 30 days, 6 months, 1 year, 2 years, 3 years, 5 years, 10 years |
|
Secondary |
Permanent pacemaker implantation |
|
Predischarge, 30 days, 6 months, 1 year, 2 years, 3 years, 5 years, 10 years |
|
Secondary |
Device success |
Defined according to consensus document from the mitral valve academic research consortium (MVARC). |
Immediately after procedure |
|
Secondary |
Infective endocarditis |
Number of patients with infective endocarditis. |
Predischarge, 30 days, 6 months, 1 year, 2 years, 3 years, 5 years, 10 years |
|
Secondary |
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 |
|
Secondary |
Acute kidney injury |
|
Predischarge, 30 days |
|
Secondary |
New-onset atrial fibrillation |
|
Predischarge, 30 days, 6 months, 1 year, 2 years, 3 years, 5 years, 10 years |
|
Secondary |
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 |
|
Secondary |
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 |
|
Secondary |
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 |
|
Secondary |
Modified Rankin scale score |
|
30 days, 6 months, 1 year, 2 years, 3 years, 5 years, 10 years |
|
Secondary |
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 |
|
Secondary |
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 |
|
Secondary |
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 |
|
Secondary |
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 |
|
Secondary |
Device embolization or single leaflet device attachment |
|
Predischarge, 30 days, 6 months, 1 year, 2 years, 3 years, 5 years, 10 years |
|
Secondary |
Effective regurgitant orifice area |
|
Predischarge, 30 days, 6 months, 1 year, 2 years, 3 years, 5 years, 10 years |
|
Secondary |
Regurgitant volume |
|
Predischarge, 30 days, 6 months, 1 year, 2 years, 3 years, 5 years, 10 years |
|
Secondary |
Regurgitant fraction |
|
Predischarge, 30 days, 6 months, 1 year, 2 years, 3 years, 5 years, 10 years |
|
Secondary |
Mitral valve area |
|
Predischarge, 30 days, 6 months, 1 year, 2 years, 3 years, 5 years, 10 years |
|
Secondary |
Mean mitral valve gradient |
|
Predischarge, 30 days, 6 months, 1 year, 2 years, 3 years, 5 years, 10 years |
|
Secondary |
Left ventricular ejection fraction (LVEF) |
|
Predischarge, 30 days, 6 months, 1 year, 2 years, 3 years, 5 years, 10 years |
|
Secondary |
Left ventricular end-diastolic diameter (LVEDD) |
|
Predischarge, 30 days, 6 months, 1 year, 2 years, 3 years, 5 years, 10 years |
|
Secondary |
Left ventricular end-systolic diameter (LVESD) |
|
Predischarge, 30 days, 6 months, 1 year, 2 years, 3 years, 5 years, 10 years |
|
Secondary |
Pulmonary artery systolic pressure (PASP) |
|
Predischarge, 30 days, 6 months, 1 year, 2 years, 3 years, 5 years, 10 years |
|
Secondary |
Right ventricular systolic pressure (RVSP) |
|
Predischarge, 30 days, 6 months, 1 year, 2 years, 3 years, 5 years, 10 years |
|
Secondary |
Left ventricular mass |
|
Predischarge, 30 days, 6 months, 1 year, 2 years, 3 years, 5 years, 10 years |
|
Secondary |
BNP and/or NT-proBNP levels |
|
Predischarge, 30 days, 6 months, 1 year, 2 years, 3 years, 5 years, 10 years |
|