A prospective registry of physical and psychological functional status after surgical or transcatheter aortic valve replacement in patients with aortic valve stenosis.
Not Applicable
- Conditions
- Aortic valve stenosis
- Registration Number
- JPRN-UMIN000032353
- Lead Sponsor
- Tokushima Red Cross Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 200
Inclusion Criteria
Not provided
Exclusion Criteria
Need for emergency surgery, clinical instability, concomitant replacement or repair of another heart valve or the aorta, difficult to undergoing physical or psychological function test, informed consent was not obtained.
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Ambulation status at a week, 1, 6 and 12 months after procedure. Ambulation status is evaluated with 6-min walk test.
- Secondary Outcome Measures
Name Time Method Cumulative survival rate after procedure. Re-admission after procedure. Physical function at a week, 1, 6 and 12 months after procedure. Mini-mental state examination at a week, 1, 6 and 12 months after procedure. SF-12 at 1, 6 and 12 months after procedure. NYHA classification at a week, 1, 6 and 12 months after procedure. Katz index of ADL at a week, 1, 6 and 12 months after procedure.