Home-Based Cardiac Rehabilitation Using a Novel Mobile Health Exercise Regimen Following Transcatheter Heart Valve Interventions
Sponsor: Vanderbilt University Medical Center
Trial Details
| Condition | Valvular Heart Disease |
| Intervention | HBCR hands-off; HBCR interactive |
| Phase | NA |
| Status | Recruiting |
| Participants | 240 |
| Est. Completion | 1 Mar 2027 |
| Last Updated | 15 May 2026 |
Primary Outcome
Probability of the hierarchical clinical event composite; Average daily total activity counts
Eligibility Criteria
Inclusion Criteria
Inclusion Criteria: * Treated with a transcatheter heart valve intervention (e.g., transcatheter aortic valve implantation \[in the native valve or valve-in-valve\], mitral transcatheter edge-to-edge repair, mitral valve-in-valve) of the aortic, mitral, or tricuspid valve done via transfemoral access Exclusion Criteria: * Unwilling or unable to provide informed consent * Not adherent to wearing the ActiGraph activity tracker during the roll-in phase for a minimum of 4 (out of 7) compliant days (worn \>10 hours/day) * Planned participation in center based cardiac rehabilitation (CBCR) * Transcatheter heart valve intervention done via any route other than a transfemoral approach * Stroke during or immediately after the transcatheter heart valve intervention prior to randomization * Placement of a pacemaker within 6 weeks prior to the transcatheter heart valve intervention or after the transcatheter heart valve intervention and prior to randomization * Those who require a walker or who cannot get out of a chair/bed on their own and walk independently (use of a cane is acceptable) * Physical or neuropsychiatric limitations that would prevent proficient use of the study tools and successful completion of the physical and quality of life assessments (e.g. blindness, dementia) * Planned surgery within 6 months after the heart valve intervention * Planned discharge from hospital to hospice, assisted living, or inpatient rehabilitation facility (discharge to a senior facility permitted as long as they are considered Independent Living) * Treating provider or site PI indicates that participation in the study would be unsafe * Participation in any ongoing randomized trial that has not completed follow-up unless the sponsor of the other trial allows enrollment of the participant in this cardiac rehabilitation trial * Unable to complete the baseline study visit prior to 6 weeks after the transcatheter heart valve intervention
Trial Sites
Countries
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