Clinical trial Recruiting at 1 site Interventional Ages 18 and up

CardioHeartConnect: Home Peloton cardiac rehab after TAVR

Official title: CardioHeartConnect: Commercially Available Fitness mHealth for Cardiac Rehabilitation Among Individuals Recovering From Transcatheter Aortic Valve Replacement

Run by University of Colorado, Denver · NCT07008911 · Data updated 2026-11-12

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.

More Aortic Valve Stenosis trials

Quick facts

Study typeInterventional
Ages18 Years and up
SexAll
Enrollment200 (estimated)
SponsorUniversity of Colorado, Denver
Academic / other
Locations1 site (Aurora, Colorado)
StatusRecruiting
StartedAugust 29, 2025
Main results expectedAugust 1, 2029
Study endsAugust 1, 2029
Registry record updatedSeptember 21, 2026
Trial IDNCT07008911 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a 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.

Probably 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.

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

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.

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 gone: 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.

Who can join: the full rules

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 it's running

  • UCHealth Structural Heart and Valve Clinic
    Aurora, Colorado, United States
    Recruiting

Study contacts

Similar studies

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

  • EmStop Embolic Protection System for TAVR in Aortic Valve Stenosis

    This study tests whether the EmStop protective device can safely capture and remove debris during transcatheter aortic valve replacement in adults with severe aortic valve stenosis.

    Recruiting at 7 sites EmStop Inc · Thousand Oaks, California and 6 other locations · NCT07276711

  • Tracking progression and consequences of heart valve disease

    This project will follow adults with moderate or worse valve disease to see if clinical tests and imaging can predict when their condition will get worse.

    Recruiting at 15 sites Second Affiliated Hospital, Zhejiang University, School of Medicine · Fuzhou, Fujian and 14 other locations · NCT07267117

  • Investigating multiple and mixed heart valve diseases

    This study looks at how common different types of heart valve diseases are and their features by gathering information from patients around the world who have been diagnosed with these conditions.

    Recruiting Assistance Publique - Hôpitaux de Paris · Paris, Île-de-France Region · NCT06235385

  • Transcatheter Aortic Valve Replacement Registry for Outcomes and Quality Monitoring

    This registry collects information from hospitals about patients undergoing TAVR to see how care and outcomes compare to guidelines and nationwide data.

    Recruiting American College of Cardiology · Washington D.C., District of Columbia · NCT07908355

  • Vericiguat to slow calcific aortic valve narrowing

    This trial tests whether vericiguat can slow the progression of mild-to-moderate calcific aortic valve stenosis compared with placebo.

    Recruiting Phase 2 West China Hospital · Chengdu, Sichuan · NCT07715279

  • CHATEAU Registry: Real-world outcomes after TAVR

    This registry collects real-world data from adults who had TAVR between 2021 and 2025 to see how they do over time and how valve performance holds up.

    Recruiting Eunpyeong St. Mary's Hospital · Seoul · NCT07709858

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.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.