Status:
RECRUITING
Home-Based Cardiac Rehabilitation Using a Novel Mobile Health Exercise Regimen Following Transcatheter Heart Valve Interventions
Lead Sponsor:
Vanderbilt University Medical Center
Collaborating Sponsors:
Medical University of South Carolina
University of Pittsburgh
Conditions:
Valvular Heart Disease
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
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 in...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
December 15 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 1 2026
Estimated Enrollment :
375 Patients enrolled
Trial Details
Trial ID
NCT06077201
Start Date
December 15 2023
End Date
October 1 2026
Last Update
August 26 2025
Active Locations (1)
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1
Vanderbilt University Medical Center
Nashville, Tennessee, United States, 37203