CardioHeartConnect for Aortic Valve Stenosis

Overseen By Madeline Balser, MPH, MSW

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Colorado, Denver

Disqualifiers: Inappropriate for cardiac rehabilitation

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 20

Duration: 8 weeks

200 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

Who Is on the Research Team?

Jennifer Portz, PhD, MSW

Principal Investigator

University of Colorado, Denver

Christopher Knoepke, PhD, MSW

Principal Investigator

University of Colorado, Denver

Are You a Good Fit for This Trial?

This trial is for US residents recovering from aortic valve replacement who can stand (with aid if needed), speak English, and use the Peloton App. They should be deemed appropriate for cardiac rehab by UCHealth's team but haven't been excluded from rehab.

Inclusion Criteria

Community-dwelling

Able to speak and understand English

I can stand up with or without help from a device.

Exclusion Criteria

Determined to be inappropriate for cardiac rehabilitation referral by the UCHealth Structural Heart and Valve Clinic team

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive an eight-week mobile cardiac rehabilitation intervention using Peloton fitness modules or educational control materials

8 weeks

Baseline assessment, 8-week assessment

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 months

12-month assessment

What Are the Treatments Tested in This Trial?

Interventions

• CardioHeartConnect
• CardioHeartEd

Trial Overview The study compares CardioHeartConnect, an eight-week program using Peloton fitness modules, with CardioHeartEd, focusing on education. It aims to see which improves physical activity and health after heart valve surgery.

How Is the Trial Designed?

Group I: CardioHeartConnect (CHC, Peloton Modules) Experimental Treatment 1 Intervention

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).

Group II: CardioHeartEd (CHE, Informational Materials) Active Control 1 Intervention

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.

Who Is Running the Clinical Trial?

University of Colorado, Denver

Lead Sponsor

Trials

1,842

Recruited

3,028,000+

National Heart, Lung, and Blood Institute (NHLBI)

Collaborator

Trials

3,987

Recruited

47,860,000+