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Recruiting NCT07008911

NCT07008911 CardioHeartConnect: Commercially Available Fitness for Cardiac Rehabilitation

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Clinical Trial Summary
NCT ID NCT07008911
Status Recruiting
Phase
Sponsor University of Colorado, Denver
Condition Aortic Valve Stenosis
Study Type INTERVENTIONAL
Enrollment 200 participants
Start Date 2025-09-30
Primary Completion 2029-08-01

Eligibility & Interventions

Sex All sexes
Min Age 18 Years
Max Age N/A
Study Type INTERVENTIONAL
Interventions
CardioHeartConnectCardioHeartEd

Eligibility Fast-Check

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What to Expect as a Participant

You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.

This trial targets 200 participants in total. It began in 2025-09-30 with a primary completion date of 2029-08-01.

⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.

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.

Eligibility 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

Contact & Investigator

Central Contact

Joshua Rosen

✉ joshua.rosen@cuanschutz.edu

📞 303-724-1889

Principal Investigator

Jennifer Portz, PhD, MSW

PRINCIPAL INVESTIGATOR

University of Colorado, Denver

Frequently Asked Questions

Who can join the NCT07008911 clinical trial?

This trial is open to participants of all sexes, aged 18 Years or older, studying Aortic Valve Stenosis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.

Is NCT07008911 currently recruiting?

Yes, NCT07008911 is actively recruiting participants. Contact the research team at joshua.rosen@cuanschutz.edu for enrollment information.

Where is the NCT07008911 trial being conducted?

This trial is being conducted at Aurora, United States.

Who is sponsoring the NCT07008911 clinical trial?

NCT07008911 is sponsored by University of Colorado, Denver. The principal investigator is Jennifer Portz, PhD, MSW at University of Colorado, Denver. The trial plans to enroll 200 participants.

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