RecruitingNANCT06077201

Home-Based Cardiac Rehabilitation Using a Novel Mobile Health Exercise Regimen Following Transcatheter Heart Valve Interventions

Sponsor: Vanderbilt University Medical Center

Trial Details

ConditionValvular Heart Disease
InterventionHBCR hands-off; HBCR interactive
PhaseNA
StatusRecruiting
Participants240
Est. Completion1 Mar 2027
Last Updated15 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

United States
View Registry Entry

This content is for educational purposes for healthcare professionals only and does not constitute clinical advice. Clinical decisions should be based on individual patient assessment, current guidelines, and appropriate specialist consultation. Editorial Standards · Privacy Policy · Terms of Service