CardioHeartConnect: Home Peloton cardiac rehab after TAVR
CardioHeartConnect: Commercially Available Fitness mHealth for Cardiac Rehabilitation Among Individuals Recovering From Transcatheter Aortic Valve Replacement
This trial tests whether an eight-week home-based Peloton program paired with a smartwatch helps people recovering from TAVR become more active and improve heart-related health compared with educational materials.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 200 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Colorado, Denver Academic / other |
| Locations | 1 site (Aurora, Colorado) |
| Trial ID | NCT07008911 on ClinicalTrials.gov |
What this trial studies
CardioHeartConnect randomizes 200 patients recovering from transcatheter aortic valve replacement to an eight-week home-based cardiac rehabilitation program delivered through Peloton modules and supported by the Ortus-iHealth platform, or to an attention control receiving American College of Cardiology educational materials. All participants receive a smartwatch and remote data capture from wearables, surveys, and electronic health records with assessments at baseline, 8 weeks, and 12 months. The primary outcome is change in average daily steps at 8 weeks, and secondary outcomes include functional capacity, cardiovascular health metrics, quality of life, self-efficacy, safety events, and participation in traditional cardiac rehab. The trial emphasizes remote delivery to improve access for patients with comorbidities or those in rural and underserved areas.
Who should consider this trial
Good fit: Adults in the United States who are community-dwelling, recovering from TAVR, considered appropriate for cardiac rehabilitation referral, able to stand, able to use a phone/tablet/computer to view Peloton content, and able to speak and understand English.
Not a fit: Patients who cannot use the Peloton app or a smartwatch, non-English speakers, those judged inappropriate for cardiac rehabilitation referral, or those who require supervised in-person rehabilitation are unlikely to benefit from this home-based program.
Why it matters
Potential benefit: If successful, it could broaden access to effective cardiac rehabilitation after TAVR and increase physical activity, functional capacity, and quality of life without requiring in-person attendance.
How similar studies have performed: Home-based and digital cardiac rehabilitation programs have improved uptake and activity in other cardiac populations, but use of commercial platforms like Peloton specifically after TAVR is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Appropriate for cardiac rehabilitation (CR) referral, as determined by the UCHealth Structural Heart \& Valve Clinic team * Community-dwelling * Reside in the United States * Able to speak and understand English * Able to provide informed consent * Able to stand with or without an assistive device * Able to see and hear content on the Peloton App via phone, tablet, or computer Exclusion Criteria: \- Determined to be inappropriate for cardiac rehabilitation referral by the UCHealth Structural Heart and Valve Clinic team
Where this trial is running
Aurora, Colorado
- UCHealth Structural Heart and Valve Clinic — Aurora, Colorado, United States (Recruiting)
Study contacts
- Principal investigator: Jennifer Portz, PhD, MSW — University of Colorado, Denver
- Study coordinator: Joshua Rosen
- Email: joshua.rosen@cuanschutz.edu
- Phone: 303-724-1889
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.