Transcatheter Closure of Paravalvular Leaks: Evaluation study post Deployment; Prospective Registry
Not Applicable
Recruiting
- Conditions
- Post transcatheter closure of paravalvular leak using Occultech PLD device in RESEAL trial
- Registration Number
- JPRN-UMIN000033433
- Lead Sponsor
- Kyushu University Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 30
Inclusion Criteria
Not provided
Exclusion Criteria
1) Those who are or will be enrolled in other clnical trials. 2) Those who are deemed as inappropriate as subjects of study by institutional investigators.
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Prognosis of patients underwent transcatheter closure of paravalvular leaks : heart failure admissions, cardiovascular interventions( surgery, catheter intervention, device therapy), mortality(all-cause, cardiovascular)
- Secondary Outcome Measures
Name Time Method Improvement of heart failure as assess by PVL grade,BNP,MLWHFQ,6MWD and NYHA class and improvement of hemolytic anemia as assessed by hemoglobin, reticulocyte, LDH, serum bilirubin.