Aortic Valve StenosisNCT07008911
CardioHeartConnect: Commercially Available Fitness for Cardiac Rehabilitation
A study testing CardioHeartConnect and CardioHeartEd in people with Aortic Valve Stenosis and Aortic Valve Disease, run by University of Colorado, Denver at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Aortic Valve Stenosis, Aortic Valve Disease
- What is being tested?
- CardioHeartConnect and CardioHeartEd
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteUnited States
- Study dates
- 29 Aug 2025to 1 Aug 2029
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Determined to be inappropriate for cardiac rehabilitation referral by the UCHealth Structural Heart and Valve Clinic team
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
UCHealth Structural Heart and Valve Clinic
Aurora, Colorado, 80045
Joshua Rosen, 303-724-1889, joshua.rosen@cuanschutz.edu
About this study
Official title: CardioHeartConnect: Commercially Available Fitness mHealth for Cardiac Rehabilitation Among Individuals Recovering From Transcatheter Aortic Valve Replacement
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.
Read the detailed description
Despite strong evidence supporting cardiac rehabilitation (CR), participation following transcatheter aortic valve replacement (TAVR) remains low, particularly among patients with comorbidities, from underserved populations, or in rural areas. This randomized controlled trial tests the effectiveness and implementation of CardioHeartConnect (CHC), an eight-week, home-based cardiac rehabilitation intervention delivered through the commercially available Peloton app and supported by the Ortus-iHealth platform.
Two hundred patients recovering from TAVR at the UCHealth Structural Heart and Valve Clinic will be randomized 1:1 to either CardioHeartConnect or an attention control group, CardioHeartEd (CHE), which receives American College of Cardiology educational materials. All participants receive a smartwatch and access to the Ortus platform for data capture. CHC participants complete daily Peloton modules focusing on low-impact exercises including walking, stretching, yoga, and strength, tailored to CR guidelines and monitored by the research team.
The primary outcome is change in physical activity, measured by average daily steps at 8 weeks. Secondary outcomes include functional capacity (Duke Activity Status Index, VO2 max), cardiovascular health status (Life's Essential 8), health-related quality of life (Kansas City Cardiomyopathy Questionnaire), and self-efficacy. Safety events, participation in traditional CR, and implementation outcomes guided by the RE-AIM framework will also be assessed. Participants are followed for 12 months post-randomization.
This trial aims to inform scalable, equitable strategies for delivering CR through commercially available mobile health tools, particularly for patients who are underserved or waitlisted for traditional programs.
- Conditions
- Aortic Valve Stenosis, Aortic Valve Disease
- Being tested
- CardioHeartConnect, CardioHeartEd
- Keywords
- Cardiac Rehabilitation, Transcatheter Aortic Valve Replacement, TAVR, Mobile Health, Peloton
- Medical subject headings
- Aortic Valve Stenosis, Aortic Valve Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CardioHeartConnectBehavioural
Also called CHC
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).
CardioHeartEdBehavioural
Also called CHE
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.
| Study group | Role | What they receive |
|---|---|---|
| CardioHeartConnect (CHC, Peloton Modules) | Experimental | 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). Receives: Behavioral: CardioHeartConnect |
| CardioHeartEd (CHE, Informational Materials) | Active comparator | 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. Receives: Behavioral: CardioHeartEd |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline to 8 weeks (Primary); 8 weeks, and 12 months (Secondary)
Secondary outcomes (6)
Change in functional capacity (self report)
Change in self-reported functional capacity measured by the Duke Activity Status Index (DASI) to assess physical function and cardiovascular fitness.
Measured: Baseline, 8 weeks, and 12 months
Changes in functional capacity (smart watch)
Estimated V02 max is generated with heart rate and motion data from smart watches. This is a measure of the maximum amount of oxygen your body can consume during exercise, useful for the very fit to those managing illness. A higher V02 max indicates a higher level of cardio fitness and endurance.
Measured: Baseline, 8 weeks, 12 months
Change in cardiovascular-related quality of life
Changes in Kansas City Cardiomyopathy Questionnaire (KCCQ) to assess symptom burden, well-being, and overall cardiovascular health.
Measured: Baseline, 8 weeks, and 12 months
Changes in cardiovascular health status
Life's Essential 8 domains including diet, physical activity, nicotine exposure, sleep, BMI, blood pressure, cholesterol, and blood glucose.
Measured: Baseline, 8 weeks, and 12 months
Healthcare utilization
Routine clinical visits, urgent care and emergency department visits, all cause hospitalizations
Measured: 8 weeks, 12 months
Changes in self-efficacy
Self-Efficacy for Managing Chronic Disease 6-item to assess ability to manage cardiovascular health.
Measured: Baselin, 8 weeks, 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2025
- Study start29 Aug 2025
- Primary completion1 Aug 2029 (estimated)
- Study completion1 Aug 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Aortic Valve StenosisStudies of the same condition, open and under way.
- More trials run by University of Colorado, DenverThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be randomized to either the exercise modules (intervention) group or the education only (control) group
- Masking
- Triple blind
- Who is masked
- Care provider, Investigator, Outcomes assessor
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Sponsor
- Investigators
- Jennifer Portz, PhD, MSW, Principal investigator, University of Colorado, DenverChristopher Knoepke, PhD, MSW, Principal investigator, University of Colorado, Denver
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07008911
- Sponsor's protocol ID
- 24-0628
- Other IDs
- R61HL169336
- Status last verified
- Sep 2026
- First submitted
- 23 May 2025
- Last updated
- 21 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No