Home-based cardiac rehabilitation after heart valve procedures

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial evaluates a home-based cardiac rehabilitation (HBCR) program delivered through a custom mobile app for patients who have undergone transcatheter heart valve interventions. Participants who are not planning to attend center-based cardiac rehabilitation will be randomized into three groups: a control group, a hands-off HBCR group, and an interactive HBCR group. The intervention aims to improve health behaviors and includes traditional cardiac rehabilitation components, with participants receiving either a 12-week or 24-week intervention. The study seeks to address the barriers that prevent individuals from participating in conventional rehabilitation programs.

Why it matters

Who can join: the full rules

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

Where it's running

• Vanderbilt University Medical Center
  Nashville, Tennessee, United States Recruiting

Study contacts

• Principal investigator: Brian R. Lindman, MD, MSc — Vanderbilt University Medical Center
• Study coordinator: Anna Vatterott, MPH
• Email: anna.vatterott@vumc.org
• Phone: 615-936-5798

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Hydra THV Transfemoral Valve Implantation in Severe Aortic Stenosis

  This registry tests how safely and effectively the Hydra THV works when implanted through the femoral artery in adults with severe symptomatic aortic stenosis.

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• Heart sound signals to detect valve and artery disease early

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• Pulmonary Vascular Disease in Valvular Heart Disease: How Valve Procedures Affect Blood Flow

  This study tests how blood flow in the lungs changes in adults with left-sided valve disease who are having valve surgery and looks to see if patterns can predict reversibility of tricuspid regurgitation and right heart dysfunction.

  Recruiting Mayo Clinic · Rochester, Minnesota · NCT07483203

• DELINEATE-Prospective: AI-assisted echocardiogram analysis for valve disease

  This project will test whether an AI system can automatically analyze echocardiograms to help doctors detect valve problems in adults who get heart ultrasounds.

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• MMVD: A Multicenter Registry to Understand Multiple and Mixed Valvular Heart Disease

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• Aortic valve sizing: comparing CT scan measurements with measurements taken during surgery for people having surgical aortic valve replacement

  This will see if CT scan measurements match the aortic valve sizes surgeons measure during surgical aortic valve replacement in adults with severe aortic stenosis.

  Recruiting Maria Cecilia Hospital · Cotignola, Ravenna · NCT07125469

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.