RecruitingNCT07008911

CardioHeartConnect: Commercially Available Fitness for Cardiac Rehabilitation

University of Colorado, DenverOne US siteView on ClinicalTrials.gov

AI Description

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.

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Who can join
adult, older adult
Participants
200
Expected completion
2029-08-01
Funded by
other

Conditions studied

Aortic Valve Disease, Aortic Valve Stenosis

What is being tested

  • BEHAVIORAL: CardioHeartConnect
  • BEHAVIORAL: CardioHeartEd

What it measures

  • Change in physical activity measured by average daily steps, Change in mean daily steps from baseline to 8 weeks, measured using smartwatch accelerometer data collected through the Ortus platform. Steps will serve as the primary endpoint to evaluate the effect of CardioHeartConnect compared with control., Baseline to 8 weeks (Primary); 8 weeks, and 12 months (Secondary)

Working with

National Heart, Lung, and Blood Institute (NHLBI)

Centers Participating

These centers are participating in this study. Reach out to them directly to learn more.

Data Sources and Methodology

Registry entry updated 2026-08-03

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