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Home exercise app program after heart valve procedures for valvular heart disease

Tests a phone app-based home rehabilitation program in people after heart valve procedures.

Key facts

Who runs it
Vanderbilt University Medical Center
Where
Nashville, United StatesSee the site
Trial code
Registry title
Home-Based Cardiac Rehabilitation Using a Novel Mobile Health Exercise Regimen Following Transcatheter Heart Valve Interventions
Status
Recruiting
People taking part
240 people, planned
Started
15 Dec 2023
Expected to end
1 Apr 2027
Type of study
Interventional, 3 groupsOne group gets no study treatment, for comparison.
Treatments tested
  • HBCR hands-off
  • HBCR interactive
Record updated
4 September 2026

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults who had a heart valve procedure through a catheter in the groin and do not plan center-based cardiac rehabilitation. It tests home-based rehabilitation using a phone app.

Age
18 Years and older
Sex
All sexes can join
Disease stage
Heart valve disease of the aortic, mitral or tricuspid valve, treated with a catheter procedure through the groin (transfemoral access).
Earlier treatment
Must have had a transcatheter heart valve intervention, for example transcatheter aortic valve implantation or mitral transcatheter edge-to-edge repair, done via transfemoral access.

Main reasons for not taking part

  • Plans to join center-based cardiac rehabilitation
  • Did not wear the ActiGraph activity tracker for at least 4 of 7 days (over 10 hours/day) in the roll-in phase
  • Stroke during or right after the valve procedure, or a pacemaker placed within 6 weeks before or after it before randomization
  • Needs a walker or cannot get up and walk alone (a cane is allowed)
  • Planned surgery within 6 months, or planned discharge to hospice, assisted living or inpatient rehabilitation

The registry criteria, word for word

Show all 14 criteriaShow less

Who can take part

  • 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

Who cannot take part

  • 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
  • Unable to complete the baseline study visit prior to 6 weeks after the transcatheter heart valve intervention
  • Planned participation in center based cardiac rehabilitation (CBCR)
  • Transcatheter heart valve intervention done via any route other than a transfemoral approach
  • 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
  • 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
  • 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)
  • 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)
  • 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

Where in United States

  • Vanderbilt University Medical CenterNashville, United StatesContact: Anna Vatterott, MPHTaking people

About the trial

What the trial wants to find out

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.

The 3 groups in the trial

  • ControlNo study treatment, for comparison

    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.

  • HBCR hands-offTreatment being tested

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

  • HBCR interactiveTreatment being tested

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

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov.
Official title
Home-Based Cardiac Rehabilitation Using a Novel Mobile Health Exercise Regimen Following Transcatheter Heart Valve Interventions
Plain-language title
Home exercise app program after heart valve procedures for valvular heart diseaseGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 14 November 2026.
Record updated
4 September 2026