Impact of Home-based Cardiac Rehabilitation on Outcomes After TAVR
HBCR-TAVR
A Study of the Impact of Home-based Cardiac Rehabilitation on Outcomes After Transcatheter Aortic Valve Replacement (TAVR)
1 other identifier
interventional
300
1 country
1
Brief Summary
To evaluate the effects of a home-based cardiac rehabilitation program for Chinese patients after Transcatheter Aortic Valve Replacement (TAVR).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started May 2020
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 26, 2019
CompletedFirst Posted
Study publicly available on registry
November 18, 2019
CompletedStudy Start
First participant enrolled
May 9, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2023
CompletedMay 12, 2020
July 1, 2019
3.6 years
August 26, 2019
May 9, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
6-minute walk test
The total distance walked in meters during 6 minutes.
6 weeks
Secondary Outcomes (8)
Number of participants die
6 weeks, 12 months
Number of participants rehospitalized
6 weeks, 12 months
Number of participants completing home-based cardiac rehabilitation
6 weeks
Cardiac function
12 months
Aortic valve function
12 months
- +3 more secondary outcomes
Study Arms (2)
Control Group
PLACEBO COMPARATORRoutine care
Interventional Group
EXPERIMENTALHome-based cardiac rehabilitation
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
The second affiliated hospital of zhejiang university, school of medicine
Hangzhou, Zhejiang, 310000, China
Related Publications (1)
Abraham LN, Sibilitz KL, Berg SK, Tang LH, Risom SS, Lindschou J, Taylor RS, Borregaard B, Zwisler AD. Exercise-based cardiac rehabilitation for adults after heart valve surgery. Cochrane Database Syst Rev. 2021 May 7;5(5):CD010876. doi: 10.1002/14651858.CD010876.pub3.
PMID: 33962483DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Xianbao Liu, Doctor
Second Affiliated Hospital, School of Medicine, Zhejiang University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 26, 2019
First Posted
November 18, 2019
Study Start
May 9, 2020
Primary Completion
December 31, 2023
Study Completion
December 31, 2023
Last Updated
May 12, 2020
Record last verified: 2019-07
Data Sharing
- IPD Sharing
- Will not share