ASAN Medical Center Aortic Valve Replacement Registry
- Conditions
- Aortic Valve Stenosis
- Interventions
- Procedure: TAVRProcedure: SAVR
- Registration Number
- NCT03298178
- Lead Sponsor
- Ho-Jin Kim
- Brief Summary
This study evaluates the effectiveness and safety of surgical aortic valve replacement and transcatheter aortic valve replacement in aortic Stenosis.
- Detailed Description
All TAVR and SAVR cases will be enrolled retrospectively and prospectively.
This registry includes sub group analysis named STRATEGY AS(Role of Sarcopenia and frailTy in pRedicting outcomes After TranscathEter or surGical aortic valve replacement in elderlY patients with Aortic Stenosis: A prospective cohort study). For this sub group analysis, all enrolled subjects will have following tests : EQ-5D, KCCQ-12(Kansas City Cardiomyopathy Questionnaire), ADL(Activities of daily living), IADL(Instrumental. Activities of Daily Living), Nagi \& Rosow-Breslau self-reported items, Previous fall events since 6 months (initial) or last visit(F/U), IPAQ(The International Physical Activity Questionnaires), Social frailty screening, CES-D(Center for Epidemiologic Studies Depression Scale), MNA-SF(Mini Nutritional Assessment - Short Form),SPPB score (Short Physical Performance Battery, usual gait speed, balance, chairstand), Multi-task gait test (counting7, animal, motor, motor\&counting7), Grip strength, Bioimpedance analysis, Muscle tone at thigh and calf, UEF (Upper extremities function).
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 6000
- All successful transcatheter aortic valve replacement or surgical aortic valve replacement
- Written consent
Exclusion Criteria
- Infective endocarditis
Not provided
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description all aortic stenosis TAVR - all aortic stenosis SAVR -
- Primary Outcome Measures
Name Time Method All cause death 1 year
- Secondary Outcome Measures
Name Time Method Vascular access site and access-related complication 1,6 and 12 months and 5 years Operation site complication 1,6 and 12 months and 5 years Prosthetic valve dysfunction 1,6 and 12 months and 5 years Prosthetic aortic valve stenosis Prosthesis-patient mismatch Prosthetic aortic valve regurgitation
Change of NYHA class 30 days and 1 year the New York Heart Association (NYHA) Functional Classification
Event rate of permanent pacemaker insertion 1,6 and 12 months and 5 years Structural valve deterioration 1,6 and 12 months and 5 years Change of valve area 30 days and 1 year Cardiovascular mortality 1,6 and 12 months and 5 years Death due to proximate cardiac cause Death caused by noncoronary vascular condition All procedure-related/surgery-related death All valve-related death Sudden or unwitnessed death Death of unknown cause
Myocardial infarction 1,6 and 12 months and 5 years Stroke 1,6 and 12 months and 5 years all stroke and TIA
Other TAVR-related complication 1,6 and 12 months and 5 years Conversion to open surgery Coronary obstruction Mitral valve apparatus damage or dysfunction Cardiac tamponade Endocarditis Valve thrombosis Valve malpositioning TAV-in-TAV deployment(TAV : Transcatheter Aortic Valve)
Free from atrial fibrillation 1,6 and 12 months and 5 years Acute kidney injury at a later date between 30 days or discharge Bleeding 1,6 and 12 months and 5 years Event rate of composite endpoint 1,6 and 12 months and 5 years Device success Early safety within 30 days Clinical efficacy after 30 days defined as death, stroke, valve dysfunction or heart failure requiring hospitalization, severe dyspnea or valve dysfunction NYHA class III or IV
Trial Locations
- Locations (1)
Asan Medical Hospital
🇰🇷Seoul, Korea, Republic of