Recruiting

CardioHeartConnect

Sponsor:

University of Colorado, Denver

Code:

NCT07008911

Conditions

Aortic Valve Stenosis

Aortic Valve Disease

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

CardioHeartConnect

CardioHeartEd

Study Details

Brief summary:

This trial evaluates the effectiveness of CardioHeartConnect, an eight-week mobile cardiac rehabilitation intervention using Peloton fitness modules, compared to educational control among patients recovering from transcatheter aortic valve replacement (TAVR). The study aims to improve physical activity, functional capacity, quality of life, and cardiovascular health using wearable devices and a digital engagement platform. A total of 200 patients will be recruited from the UCHealth Structural Heart and Valve Clinic and randomized to either CardioHeartConnect or CardioHeartEd. Participants will be assessed at baseline, 8 weeks, and 12 months using surveys, smartwatch data, and electronic health records.

Conditions

Aortic Valve Stenosis

Aortic Valve Disease

Study ID

NCT07008911

Start date

Aug 29, 2025

Status verified date

Jul, 2026

Completion date

Aug 1, 2029

Anticipated

Primary completion date

Aug 1, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

200 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: CardioHeartConnect (CHC, Peloton Modules)

Participants will receive access to an eight-week series of pre-set, clinically reviewed Peloton exercise modules delivered via the Ortus-iHealth platform. They will also receive a smartwatch designed to monitor physical activity and support engagement in cardiac rehabilitation after Transcatheter Aortic Valve Replacement (TAVR).

active comparator: CardioHeartEd (CHE, Informational Materials)

Participants will receive access to an eight-week series of cardiac rehabilitation-related educational materials developed by the American College of Cardiology, delivered through the Ortus-iHealth platform. Participants in this arm will also receive a smartwatch to parallel the intervention group and support activity tracking.

Interventions

CardioHeartConnect

Participants in the CardioHeartConnect group engage in an eight-week digital cardiac rehabilitation program using the commercially available Peloton app. The intervention includes two daily modules (10-25 minutes total) on weekdays, focused on walking, strength, low-intensity cardio, yoga, pilates, and stretching. Modules progress in intensity over time. The program is delivered through the Ortus-iHealth platform, which prompts daily participation and integrates survey responses and smartwatch data. The intervention is designed to support physical activity, functional capacity, quality of life, and cardiovascular health among patients recovering from Transcatheter Aortic Valve Replacement (TAVR).

CardioHeartEd

CardioHeartEd is the control condition in which participants receive weekly cardiac rehabilitation-related educational resources through the Ortus-iHealth platform for eight weeks. The content is created by the American College of Cardiology and is designed to promote cardiovascular health following TAVR. Participants also receive a smartwatch to wear for self-monitoring, but do not receive structured exercise content. The CHE group controls for access to technology and general education about heart health.

Primary outcome measure

  • Change in physical activity measured by average daily steps [ Time Frame: Baseline to 8 weeks (Primary); 8 weeks, and 12 months (Secondary) ]

Central Contacts and Locations

Central contacts

Joshua Rosen

303-724-1889joshua.rosen@cuanschutz.edu

Madeline Balser, MPH, MSW

303-724-1883madeline.balser@cuanschutz.edu

Locations

UCHealth Structural Heart and Valve Clinic

Recruiting

Aurora, Colorado, United States, 80045

Contacts

Joshua Rosen

303-724-1889joshua.rosen@cuanschutz.edu

More Information

Sponsor

University of Colorado, Denver

Last update posted

Aug 3, 2026

Last verified

Jul, 2026

Keywords

  • Cardiac Rehabilitation
  • Transcatheter Aortic Valve Replacement
  • TAVR
  • Mobile Health
  • Peloton

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Colorado, Denver on 2026-08-03.