Recruiting

Cardiac Rehabilitation

Sponsor:

Vanderbilt University Medical Center

Code:

NCT06077201

Conditions

Valvular Heart Disease

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

HBCR hands-off

HBCR interactive

Study Details

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 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

Valvular Heart Disease

Study ID

NCT06077201

Start date

Dec 15, 2023

Status verified date

Sep, 2026

Completion date

Apr 1, 2027

Anticipated

Primary completion date

Feb 1, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

240 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

no intervention: Control

Standard of care course for an individual not participating in center based cardiac rehabilitation. AHA Life's Essential 8 Fact Sheets are provided to promote healthy living.

experimental: HBCR hands-off

Home-based cardiac rehabilitation with mobile application + AHA Life's Essential 8 sheets.

experimental: HBCR interactive

Home-based cardiac rehabilitation with mobile application and periodic video calls with exercise physiologist + AHA Life's Essential 8 sheets.

Interventions

HBCR hands-off

Home-based cardiac rehabilitation intervention facilitated by a custom app to deliver education, counseling on healthy living and modification of risk factors, mindfulness, and physical activity guidance.

HBCR interactive

Home-based cardiac rehabilitation intervention facilitated by a custom app to deliver education, counseling on healthy living and modification of risk factors, mindfulness, and physical activity guidance. Additionally, there are periodic video calls with an exercise physiologist.

Primary outcome measure

  • Probability of the hierarchical clinical event composite [ Time Frame: Over the entire available follow-up period for randomized participants (minimum of 6 months, maximum approximately 24-30 months). ]
  • Average daily total activity counts [ Time Frame: The actigraphy device will be worn for approximately one week and, using data from days when the device was worn >10 hours, the average daily total activity counts determined. The primary comparison will be at 12 weeks after randomization. ]

Central Contacts and Locations

Central contacts

Anna Vatterott, MPH

615-936-5798anna.vatterott@vumc.org

Caleb Hayes, MPH

caleb.hayes@vumc.org

Locations

Vanderbilt University Medical Center

Recruiting

Nashville, Tennessee, United States, 37203

Contacts

Anna Vatterott, MPH

615-936-5798anna.vatterott@vumc.org

Caleb Hayes, MPH

caleb.hayes@vumc.org

Principal Investigator:

Brian R. Lindman, MD, MSc

More Information

Sponsor

Vanderbilt University Medical Center

Last update posted

Sep 4, 2026

Last verified

Sep, 2026

Keywords

  • cardiac rehabilitation
  • transcatheter heart valve intervention
  • cardiology
  • aortic stenosis
  • mitral regurgitation
  • tricuspid regurgitation

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Vanderbilt University Medical Center on 2026-09-04.