Impact of Home-based Cardiac Rehabilitation on Outcomes After TAVR

Aortic Stenosis Clinical Trial

— HBCR-TAVR  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04166682
• Other study ID #: ZJUWXY
• Status: Recruiting
• Phase: N/A
• Start date: May 9, 2020
• Est. completion date: December 31, 2023

Study information

• Verified date: July 2019
• Source: Second Affiliated Hospital, School of Medicine, Zhejiang University
• Contact: Xiaoya Wang, Doctor
• Phone: +86-15715702712
• Email: wxyonce[@]zju.edu.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: December 31, 2023
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Aortic Stenosis
• Aortic Valve Stenosis

Intervention

Behavioral:
• Home-based cardiac rehabilitation
cardiac rehabilitation done at home
• Routine care
Routine care and followup

Locations

Country	Name	City	State
China	The second affiliated hospital of zhejiang university, school of medicine	Hangzhou	Zhejiang

Sponsors (1)

Lead Sponsor	Collaborator
Second Affiliated Hospital, School of Medicine, Zhejiang University

Country where clinical trial is conducted

China, 

Outcome

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