ASAN Medical Center Aortic Valve Replacement Registry
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- Ho-Jin Kim
- 入组人数
- 900
- 试验地点
- 1
- 主要终点
- All cause death
研究概览
简要总结
This study evaluates the effectiveness and safety of surgical aortic valve replacement and transcatheter aortic valve replacement in aortic Stenosis.
详细描述
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).
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All successful transcatheter aortic valve replacement or surgical aortic valve replacement
- •Written consent
- •Exclusion Criteria
- •Infective endocarditis
排除标准
- 未提供
结局指标
主要结局
All cause death
时间窗: 1 year
次要结局
- Operation site complication(1,6 and 12 months and 5 years)
- Prosthetic valve dysfunction(1,6 and 12 months and 5 years)
- Change of NYHA class(30 days and 1 year)
- 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)
- Myocardial infarction(1,6 and 12 months and 5 years)
- Stroke(1,6 and 12 months and 5 years)
- Other TAVR-related complication(1,6 and 12 months and 5 years)
- Free from atrial fibrillation(1,6 and 12 months and 5 years)
- Vascular access site and access-related complication(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)