Remote Patient Management for Cardiac Arrhythmias
(RPM CIED Tachy Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores how remote patient management (RPM) can assist individuals with cardiac arrhythmias, which are irregular heartbeats. The researchers aim to determine if remote monitoring is as effective as the usual care involving regular in-clinic visits. Participants will receive either only remote follow-ups or a combination of remote and in-person care. Those with a defibrillator from Medtronic, Abbott, or Boston Scientific who can use remote monitoring tools might be suitable for this trial. As an unphased trial, this study provides a unique opportunity to contribute to innovative research that could enhance future cardiac care.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications.
What prior data suggests that Remote Patient Management is safe for cardiac arrhythmias?
Studies have shown that managing heart rhythm problems remotely is generally well-received by patients. Research indicates that wearable devices and remote monitoring can help detect and track heart rhythm issues early. This method allows doctors to monitor patients closely without frequent in-person visits.
Reports suggest that remote management is safe and enhances patient care by enabling quicker responses to changes in heart health. So far, no major reports have linked negative effects directly to remote monitoring. This approach is gaining popularity as it helps patients manage their condition more independently while staying connected with healthcare providers.12345Why are researchers excited about this trial?
Researchers are excited about remote patient management for cardiac arrhythmias because it offers a more continuous and convenient way to monitor heart conditions compared to traditional methods. Unlike the standard care that involves periodic in-clinic visits, remote management allows for real-time data collection and patient monitoring from the comfort of home. This approach not only reduces the need for frequent hospital visits but also enables quicker response to any irregular heart activity, potentially leading to better patient outcomes and quality of life.
What evidence suggests that this trial's treatments could be effective for cardiac arrhythmias?
This trial will compare Remote Patient Management with Standard of Care for cardiac arrhythmias. Research has shown that managing heart rhythm problems from home can be very effective. Studies have found that remote monitoring helps catch irregular heartbeats early, which patients might not notice on their own. Wearable devices and remote systems allow for continuous tracking, making it easier to manage heart issues. In one survey, nearly 89% of patients using remote monitoring felt comfortable managing their health at home. Additionally, remote monitoring has been linked to better outcomes for patients with implanted heart devices. This method can transform heart care by providing constant supervision and timely assistance.23678
Who Is on the Research Team?
Ratika Parkash, MD FRCPC
Principal Investigator
Nova Scotia Health Authority
Are You a Good Fit for This Trial?
This trial is for individuals who can consent and have a specific Medtronic or Abbott defibrillator that supports remote monitoring. They must have a family physician and not be part of another clinical trial. It's not for those needing frequent heart clinic visits or with unreliable pacemaker function.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Remote Patient Management
Participants are managed remotely using VIRTUES and Remote View technologies, avoiding travel to specialized clinics
Standard of Care
Participants receive remote monitoring at 6-month intervals, alternating with yearly in-clinic visits
Follow-up
Participants are monitored for safety and effectiveness after the main trial period
What Are the Treatments Tested in This Trial?
Interventions
- Remote Patient Management
- Standard of Care
Remote Patient Management is already approved in United States, European Union, Canada for the following indications:
- Cardiovascular disease management
- Chronic disease management
- Post-surgical recovery
- Heart failure management
- Atrial fibrillation detection
- Chronic kidney disease management
- Cardiovascular implantable electronic device management
- Chronic disease management
Find a Clinic Near You
Who Is Running the Clinical Trial?
Ratika Parkash
Lead Sponsor
Abbott Medical Devices
Industry Sponsor
Dr. Etahn Korngold
Abbott Medical Devices
Chief Medical Officer
Medical training at Harvard Medical School and Massachusetts General Hospital
Robert B. Ford
Abbott Medical Devices
Chief Executive Officer since 2020
Bachelor's degree from Boston College, MBA from UC Berkeley, Haas School of Business
Medtronic
Industry Sponsor
Geoff Martha
Medtronic
Chief Executive Officer since 2020
Finance degree from Penn State University
Dr. Richard Kuntz
Medtronic
Chief Medical Officer since 2023
MD, MSc
Cardiac Arrhythmia Network of Canada
Collaborator