Impact of Home-based Cardiac Rehabilitation on Outcomes After TAVR

Study Overview
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Brief Summary
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To evaluate the effects of a home-based cardiac rehabilitation program for Chinese patients after Transcatheter Aortic Valve Replacement (TAVR).

Official Title
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A Study of the Impact of Home-based Cardiac Rehabilitation on Outcomes After Transcatheter Aortic Valve Replacement (TAVR)

Conditions
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Aortic Stenosis

Intervention / Treatment
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* Behavioral: Home-based cardiac rehabilitation
* Behavioral: Routine care


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Control Group<br>Routine care | Behavioral: Routine care<br>* Routine care and followup<br>|
| Experimental: Interventional Group<br>Home-based cardiac rehabilitation | Behavioral: Home-based cardiac rehabilitation<br>* cardiac rehabilitation done at home<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 6-minute walk test | The total distance walked in meters during 6 minutes. | 6 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants die | Number of participants die during the study due to cardiovascular or non-cardiovascular causes. | 6 weeks, 12 months | 
| Number of participants rehospitalized | Number of participants rehospitalized during the study. | 6 weeks, 12 months | 
| Number of participants completing home-based cardiac rehabilitation | Number of participants completing home-based cardiac rehabilitation | 6 weeks | 
| Cardiac function | Ejection fraction estimated by echocardiography | 12 months | 
| Aortic valve function | Aortic valve function estimated by echocardiography | 12 months | 
| Number of participants injured | Number of participants injured or die during the course of home-based cardiac rehabilitation | 6 weeks | 
| Time spent performing activities | Number of minutes in a typical week that participants spent performing activities | 6 weeks, 12 months | 
| 6-minute walk test | The total distance walked in meters during 6 minutes | 12 months |