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 explores how a digital cardiac rehab program using Peloton fitness modules can assist patients recovering from a heart valve procedure called TAVR. The program aims to boost physical activity, improve heart health, and enhance quality of life by tracking progress with smartwatches. Participants will either engage in Peloton exercises or receive educational materials (CardioHeartEd), with their progress monitored over time. Ideal candidates have undergone TAVR, are eligible for cardiac rehab, can stand with or without assistance, and can use the Peloton app on a device. As an unphased trial, this study offers patients the chance to contribute to innovative research that could enhance cardiac rehabilitation options.

Do I have to stop taking my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that the CardioHeartConnect intervention is safe for patients recovering from TAVR?

Research has shown that using mobile fitness tools like Peloton for heart rehab is generally safe. CardioHeartConnect, a program that uses these tools, aids patients in recovering after a heart procedure called TAVR. Due to the popularity and widespread use of these fitness tools, they have a strong safety record.

The program emphasizes exercise and activity tracking, which are usually safe. Participants might experience common exercise side effects like muscle soreness or tiredness, but these are typically mild. It is important to follow a doctor's advice when starting a new exercise routine, especially after a medical procedure. No reports have indicated serious problems specifically linked to CardioHeartConnect. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the CardioHeartConnect trial because it explores innovative ways to support cardiac rehabilitation for patients with aortic valve stenosis, particularly after Transcatheter Aortic Valve Replacement (TAVR). Unlike traditional rehab programs that may require in-person visits and standardized protocols, this trial uses a digital approach to deliver personalized exercise modules through Peloton, making it more accessible and engaging. Participants also receive smartwatches to track their activity, which can help tailor the rehabilitation to individual needs and encourage consistent participation. This trial could pave the way for more flexible and personalized cardiac care, enhancing recovery and overall heart health.

What evidence suggests that CardioHeartConnect could be effective for aortic valve stenosis?

Research has shown that cardiac rehab programs, such as CardioHeartConnect, which participants in this trial may receive, can aid recovery after heart valve procedures like TAVR. Studies have found that regular exercise through guided programs boosts fitness and improves quality of life. The Peloton fitness modules in CardioHeartConnect are designed to keep patients motivated and active. Participants in another arm of this trial will receive CardioHeartEd, which offers educational materials to support cardiac rehabilitation. Wearable devices in both programs track progress and encourage continued participation. Overall, digital rehab tools have been linked to better health outcomes for heart patients. ^{1 2 3 4 6}

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+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT07008911

CardioHeartConnect: Commercially Available Fitness for ... This trial evaluates the effectiveness of CardioHeartConnect, an eight-week mobile cardiac rehabilitation intervention using Peloton fitness modules, ...

2. jacc.org jacc.org/doi/10.1016/j.jacc.2025.03.004

5-Year Outcomes After Transcatheter or Surgical Aortic ... At 5 years, patients with severe aortic stenosis who were treated with either TAVR or surgery had comparable rates of all-cause mortality or disabling stroke.

3. sciencedirect.com sciencedirect.com/science/article/pii/S0735109725053355

5-Year Outcomes After Transcatheter or Surgical Aortic ... At 5 years, patients with severe aortic stenosis who were treated with either TAVR or surgery had comparable rates of all-cause mortality or disabling stroke.

4. trialx.com trialx.com/clinical-trials/listings/308394/cardioheartconnect-commercially-available-fitness-for-cardiac-rehabilitation/

Commercially Available Fitness for Cardiac Rehabilitation Overview. This trial evaluates the effectiveness of CardioHeartConnect, an eight-week mobile cardiac rehabilitation intervention using Peloton fitness ...

5. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/39173988/

A Systematic Review and Meta-Analysis of Randomized ... Our meta-analysis showed that TAVR is associated with similar long-term outcomes compared with SAVR in selected low-risk patients.

6. withpower.com withpower.com/trial/phase-aortic-valve-stenosis-8-2025-f0335

CardioHeartConnect for Aortic Valve Stenosis This trial evaluates the effectiveness of CardioHeartConnect, an eight-week mobile cardiac rehabilitation intervention using Peloton fitness modules, ...