Impact of SAVR and TAVR on Patient's Activity and Mobility CAPABILITY Study
试验速览
- 阶段
- 不适用
- 状态
- 暂停
- 发起方
- 入组人数
- 340
- 试验地点
- 2
- 主要终点
- 6-minute walk test (6 MWT) at 6 months
研究概览
简要总结
This is an independent, investigator-initiated, prospective multicenter observational study with restricted grant provided by Edwards Lifesciences that aims to describe baseline (preoperative) physical function and to assess and compare 6-month postoperative changes in the physical function of patients undergoing aortic stenosis (AS) treatment with either transcatheter aortic valve replacement (TAVR) or surgical aortic valve replacement (SAVR) implanted with Edwards valve type ("SAPIEN 3" and "SAPIEN XT" for TAVR; "INSPIRIS RESILIA", "EDWARDS INTUITY" and "Carpentier-Edwards PERIMOUNT Magna-Ease" for SAVR).
Secondary objectives of this study are: to evaluate the validity of wearable devices in assessing physical function in such patients and subjects' compliance in wearing the device also after a very long follow-up time up to 12 months; to assess and compare 6-month postoperative changes in Health-Related Quality of Life (HRQoL), sleep quality, cognitive function of patients undergoing AS treatment with either TAVR or SAVR.
Smart watch activity tracker "Vívoactive® HR" devices by "Garmin©" will be used in the study. Devices will be distributed to the patients at time of baseline assessment, along with a Bluetooth-paired smartphone provided with a prepaid data-only SIM-card and study-customised interface. Patients will be asked to wear the device 24 hours a day, 7 days a week, from the baseline assessment to the last follow-up, 12 months after baseline.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 75 Years 至 89 Years（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Severe native aortic valve stenosis symptomatic for heart failure or angina;
- •Indication to isolated TAVR or SAVR given by heart team;
- •TAVR through the trans-femoral approach;
- •SAVR by any access;
- •Implantation of an Edwards valve type (SAPIEN 3 and SAPIEN XT for TAVR; INSPIRIS RESILIA, EDWARDS INTUITY and Carpentier-Edwards PERIMOUNT Magna-Ease for SAVR);
- •Signed informed consent.
排除标准
- •Use of walking aids;
- •Dyskinesia or Parkinson's disease;
- •Reduced survival expectancy due to severe co-morbidities (<1 year);
- •Lack of any of inclusion criteria.
结局指标
主要结局
6-minute walk test (6 MWT) at 6 months
时间窗: 6 months after treatment with TAVR/SAVR
The 6-min walk test (6 MWT) is a submaximal exercise test that entails measurement of distance walked over a span of 6 minutes. The 6-minute walk distance (6 MWD) provides a measure for integrated global response of multiple cardiopulmonary and musculoskeletal systems involved in exercise.
6-minute walk test (6 MWT) at 1 month
时间窗: 1 month after treatment with TAVR/SAVR
The 6-min walk test (6 MWT) is a submaximal exercise test that entails measurement of distance walked over a span of 6 minutes. The 6-minute walk distance (6 MWD) provides a measure for integrated global response of multiple cardiopulmonary and musculoskeletal systems involved in exercise.
6-minute walk test (6 MWT) at 3 months
时间窗: 3 months after treatment with TAVR/SAVR
The 6-min walk test (6 MWT) is a submaximal exercise test that entails measurement of distance walked over a span of 6 minutes. The 6-minute walk distance (6 MWD) provides a measure for integrated global response of multiple cardiopulmonary and musculoskeletal systems involved in exercise.
次要结局
- Health related Quality of Life (HRQoL) assessed by the Toronto Aortic Stenosis Quality of Life Questionnaire (TASQ)(1, 3, 6 and 12 months after treatment with TAVR/SAVR)
- patients' compliance with the device(1, 3, 6 and 12 months after treatment with TAVR/SAVR)
- Sleep quality assessed by the Epworth Sleepiness Scale (ESS)(1, 3, 6 and 12 months after treatment with TAVR/SAVR)
- Patient's perceived health status assessed by the 36-Item Short Form Survey (SF-36)(1, 3, 6 and 12 months after treatment with TAVR/SAVR)
- validity of the device in measuring physical function(1, 3, 6 and 12 months after treatment with TAVR/SAVR)
- Cognitive function assessed by the Mini Mental State Examination (MMSE)(1, 3, 6 and 12 months after treatment with TAVR/SAVR)