Single center, Exploratory Safety Evaluation Study of Transcatheter Closure of Prosthetic Paravalvular Regurgitatio
Not Applicable
- Conditions
- Prosthetic paravalvular regurgitation after heart valve replacement
- Registration Number
- JPRN-UMIN000021427
- Lead Sponsor
- ational Cerebral and Cardiovascular Center
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 4
Inclusion Criteria
Not provided
Exclusion Criteria
Patients will not be considered for percutaneous repair if the following criteria were met: (1) Patients with metal allergy (2) Patients with allergy to contrast agent (3) Echocardiographic evidence of intra-cardiac mass, thrombus, or vegetation (4) Patients in shock (5) Patients who are or are posslibly, or are lactating (6) Patients who are participating, or going to participate in other clinical studies. (7) Patients judged inappropriate for the study by the principal
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1. Major complication and failure during the procedure Death, stroke, myocardial infarction, cardiac perforation, cardiac tamponade, cardiogenic shock, prosthetic valve failure, major bleeding, injury of great vessels caused by the procedure, embolism of organs, and embolism and/or malposition of the device. 2. Success rate and efficacy of the procedure Acute procedural success was defined as successful deployment of one and more occluder devices that resulted in significant reduction in paravalvular regurgitation to mild or less-residual regurgitation.
- Secondary Outcome Measures
Name Time Method