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Home-Based Cardiac Rehab After Heart Valve Procedures

This study is looking at new ways to help people recover after a transcatheter heart valve intervention (a procedure to fix heart valves without open-heart surgery). Many people don't go to traditional rehab centers, so this trial tests home-based cardiac rehabilitation (HBCR) using a special app. You would be randomized into one of three groups: a control group, an HBCR group with app-based guidance only (HBCR hands-off), or an HBCR group with app guidance plus video calls with an exercise physiologist (HBCR interactive). The study wants to see if these home-based programs improve your overall health and daily activity levels. You can join if you are 18 or older, have had a transcatheter heart valve intervention, and are not planning to attend a center-based cardiac rehab program. The study is currently recruiting 240 participants.

Study design
This is an interventional, randomized controlled trial with 240 planned participants. It compares two types of home-based cardiac rehabilitation delivered via an app to a control group.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for at least 6 months, and up to approximately 24-30 months, to track clinical events. Daily activity will be measured at 12 weeks after randomization.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06077201

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

Recruiting
NAAges 18+InterventionalTreatment
Vanderbilt University Medical Center
~240 participants
Updated 2026-05-15 on ClinicalTrials.gov
What's tested:HBCR hands-offHBCR interactive

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Probability of the hierarchical clinical event composite
Measured over Over the entire available follow-up period for randomized participants (minimum of 6 months, maximum approximately 24-30 months).
+1 more outcome measured

Conditions

Valvular Heart Disease

Explore related trials

Aortic Valve StenosisMitral Valve InsufficiencyTricuspid Valve InsufficiencyValvular Heart Disorder

Where it's being run

1 sites across 1 states
Tennessee1

Study leadership

  • Brian R. Lindman, MD, MSc · PRINCIPAL_INVESTIGATOR · Vanderbilt University Medical Center

Who to contact

Anna Vatterott, MPH
[email protected]
615-936-5798
Email the study team

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Do you actually qualify for this trial?

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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

What this trial measures

  • Probability of the hierarchical clinical event compositeOver the entire available follow-up period for randomized participants (minimum of 6 months, maximum approximately 24-30 months).

    The hierarchical clinical event composite includes (in order of hierarchy): (1) all-cause death; (2) all-cause hospitalization; and (3) skilled nursing facility visits. To examine whether the intervention improves mortality, hospitalization, and SNF rates after THVIs, we will conduct Bayesian Markov longitudinal proportional odds model on weekly outcome measures. The pooled active treatment vs. control group comparison (primary comparison for the trial) will be estimated by contrasting the average of posterior probability that Y≥y of the two active treatment groups (hands-off HBCR and interactive HBCR) to the control group.

  • Average daily total activity countsThe 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.

    Daily total activity counts are determined by a triaxial actigraphy device.