Single Institution, Exploratory, Safety Evaluation Study of Aortic Valve-in-Valve Transcatheter Aortic Valve Implantation for Degenerated Bioprosthetic Heart Valve
Not Applicable
- Conditions
- failing bioprosthetic valve in the aortic position
- Registration Number
- JPRN-UMIN000026450
- 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
- 11
Inclusion Criteria
Not provided
Exclusion Criteria
1)Patients with metal allergy 2)Patients with contrast media hypersensitivity 3)Patients with thrombus in left atrium or ventricle 4)Patients during shock state 5)Patients with failed prosthetic aortic valve induced by active infective endocarditis or during infection status 6)Patients with hemodialysis 7)Patients undergoing mechanical prosthetic aortic valve 8)Patients with possibility of pregnancy or during pregnancy or lactation 9)Patients joining other clinical trials or planning other clinical trials 10)Patients judged as inappropriate by the director or responsible doctors of this clinical trials
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Major adverse events during the procedure(Safety) until postoperative 30th day All cause mortality within 30 days post procedure All stroke within 30 days post procedure Life-threatening major bleeding within 30 days post procedure Coronary artery lesions requiring revascularization within 30 days post procedure Major vascular complications within 30 days post procedure Structural valve failure requiring re-intervention within 30 days post procedure Any other major adverse events or device related malfunctions within 30 days post procedure
- Secondary Outcome Measures
Name Time Method Procedural Success(Efficacy) Change from baseline in aortic valve function evaluated by TTE at 7 and 30 days post operatively Change from baseline in NYHA functional class measured at 7 and 30 days post operatively Change from baseline in performance of 6 minute walk test measured postoperative day 7 Change in left ventricular end-diastolic diameter (LVEDD) at 7 and 30 days post-op Change from baseline in left ventricular ejection fraction at 7 and 30 days post op Change from baseline in plasma BNP at 7 and 30 days post-op Change from baseline in pulmonary artery wedge pressure (PAWP) immediately following procedure Change from baseline in cardiac index (CI) immediately following the procedure