Impact of Home-based Cardiac Rehabilitation on Outcomes After TAVR (HBCR-TAVR)

Zhejiang University

Status: Unknown

Conditions: Aortic Stenosis

Treatments: Behavioral: Home-based cardiac rehabilitation; Behavioral: Routine care

Study type: Interventional

Funder types: Other

Identifiers

NCT04166682

ZJUWXY

Details and patient eligibility

About

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

Enrollment: 300 estimated patients

Sex: All

Ages: 65+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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300 participants in 2 patient groups, including a placebo group

Control Group

Placebo Comparator group

Description:

Routine care

Treatment:

Behavioral: Routine care

Interventional Group

Experimental group

Description:

Home-based cardiac rehabilitation

Treatment:

Behavioral: Home-based cardiac rehabilitation