Actively Recruiting
Home-Based Cardiac Rehabilitation Using a Novel Mobile Health Exercise Regimen Following Transcatheter Heart Valve Interventions
Led by Vanderbilt University Medical Center · Updated on 2026-05-07
240
Participants Needed
1
Research Sites
176 weeks
Total Duration
On this page
Sponsors
V
Vanderbilt University Medical Center
Lead Sponsor
M
Medical University of South Carolina
Collaborating Sponsor
AI-Summary
What this Trial Is About
The vast majority of cardiac rehabilitation eligible individuals do not participate in center based cardiac rehabilitation (CBCR). While steps to encourage participation in CBCR are important, many individuals will still not participate for a variety of reasons. This randomized controlled trial is evaluating a home-based cardiac rehabilitation (HBCR) intervention delivered using a custom app and digital tools in patients undergoing transcatheter heart valve interventions (THVIs). After a brief roll-in period, participants not intending to participate in CBCR are randomized to one of three groups: (1) control, (2) HBCR mobile health intervention with hands-off delivery, and (3) HBCR mobile health intervention with interactive delivery. Participants in the intervention groups (hands-off/interactive delivery) will also be randomized to continue the intervention for 12 weeks or 24 weeks. The intervention targets key health behaviors and includes traditional cardiac rehabilitation components. The study will assess the effect of the intervention on clinical events, physical activity, quality of life, and other outcomes. Those who intend to participate in CBCR will be followed in a registry.
CONDITIONS
Official Title
Home-Based Cardiac Rehabilitation Using a Novel Mobile Health Exercise Regimen Following Transcatheter Heart Valve Interventions
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Treated with a transcatheter heart valve intervention (such as transcatheter aortic valve implantation, mitral transcatheter edge-to-edge repair, or mitral valve-in-valve) on the aortic, mitral, or tricuspid valve done via transfemoral access
You will not qualify if you...
- Unwilling or unable to provide informed consent
- Not adherent to wearing the ActiGraph activity tracker during the roll-in phase for at least 4 out of 7 days (worn more than 10 hours per day)
- Planned participation in center-based cardiac rehabilitation
- Heart valve intervention done by any route other than transfemoral
- Stroke during or immediately after the heart valve intervention before randomization
- Pacemaker placed within 6 weeks before or after the heart valve intervention and before randomization
- Requires a walker or cannot get out of a chair or bed and walk independently (using a cane is acceptable)
- Physical or neuropsychiatric conditions preventing use of study tools or completion of assessments (e.g., blindness, dementia)
- Planned surgery within 6 months after the heart valve intervention
- Planned discharge to hospice, assisted living, or inpatient rehabilitation (discharge to independent living senior facility allowed)
- Treating provider or study doctor says participation would be unsafe
- Participation in ongoing randomized trials without sponsor approval
- Unable to complete baseline visit before 6 weeks after the heart valve intervention
AI-Screening
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Trial Site Locations
Total: 1 location
1
Vanderbilt University Medical Center
Nashville, Tennessee, United States, 37203
Actively Recruiting
Research Team
A
Anna Vatterott, MPH
CONTACT
C
Caleb Hayes, MPH
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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