Aortic Stenosis
Conditions
Brief summary
To evaluate the effects of a home-based cardiac rehabilitation program for Chinese patients after Transcatheter Aortic Valve Replacement (TAVR).
Interventions
BEHAVIORALHome-based cardiac rehabilitation
cardiac rehabilitation done at home
BEHAVIORALRoutine care
Routine care and followup
Sponsors
Second Affiliated Hospital, School of Medicine, Zhejiang University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Aortic stenosis accepted for TAVR * Participant able and willing to give written informed consent * Participant able (in the investigator's opinion) and willing to comply with all study requirements
Exclusion criteria
subjects may not enter the study if any of the following apply * Intervention deemed inappropriate due to co-morbidity or frailty * Life expectancy less than one year due to co-morbidity * Previous surgical aortic valve replacement (sAVR) or TAVR * Predominant aortic regurgitation
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 6-minute walk test | 6 weeks | The total distance walked in meters during 6 minutes. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of participants rehospitalized | 6 weeks, 12 months | Number of participants rehospitalized during the study. |
| Number of participants completing home-based cardiac rehabilitation | 6 weeks | Number of participants completing home-based cardiac rehabilitation |
| Cardiac function | 12 months | Ejection fraction estimated by echocardiography |
| Number of participants die | 6 weeks, 12 months | Number of participants die during the study due to cardiovascular or non-cardiovascular causes. |
| Number of participants injured | 6 weeks | Number of participants injured or die during the course of home-based cardiac rehabilitation |
| Time spent performing activities | 6 weeks, 12 months | Number of minutes in a typical week that participants spent performing activities |
| 6-minute walk test | 12 months | The total distance walked in meters during 6 minutes |
| Aortic valve function | 12 months | Aortic valve function estimated by echocardiography |
Countries
China
Contacts
Primary ContactXiaoya Wang, Doctor
Outcome results
None listed