Remote Monitoring for Pacemaker Management

(RPM CIED Brady Trial)

Recruiting at 14 trial locations

Overseen By Patricia Theoret

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Ratika Parkash

Disqualifiers: No physician access, RPM CIED study, others

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 8

848 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores the use of remote monitoring technology for individuals with pacemakers. The goal is to determine if remote monitoring can effectively track pacemaker function and health events, potentially reducing the need for in-clinic visits. Participants will either use remote monitoring or continue with traditional in-clinic check-ups. Those with a Medtronic or Abbott pacemaker capable of connecting to remote monitoring, and who frequently experience pacemaker issues, might be suitable candidates. As an unphased trial, this study offers participants the chance to contribute to innovative research that could enhance future pacemaker 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 monitoring is safe for pacemaker management?

Research has shown that remote monitoring (RM) is generally safe for individuals with heart devices. Studies have found that RM helps detect heart problems early, enabling doctors to respond more quickly, which can lead to better health outcomes for patients.

Patients appreciate RM because it saves time and money. Although RM has been successfully used with various heart devices, there is less information about its use with pacemakers. However, experts believe it remains safe and helpful for most pacemaker patients, except for those who rely entirely on their pacemakers.

Overall, RM provides a safe and effective way to monitor heart health from home. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about remote monitoring for pacemaker management because it offers a more convenient and potentially more efficient way to manage heart health compared to traditional in-clinic visits. Unlike the standard of care, which requires regular trips to the doctor's office, remote monitoring enables continuous tracking of a patient's heart activity from the comfort of their home. This method not only saves time for patients but also allows for quicker detection of any irregularities, potentially leading to faster interventions. This innovation could revolutionize how patients with pacemakers are monitored, enhancing both patient experience and care outcomes.

What evidence suggests that remote monitoring is effective for pacemaker management?

This trial will compare Remote Monitoring with Standard of Care for pacemaker management. Research has shown that remote monitoring for pacemakers is highly effective. Studies have found that it helps detect heart problems early and speeds up the response to these issues. Remote monitoring also simplifies life by saving time and money, as patients don’t need to travel for check-ups as often. This method is safe for most people with heart devices, except those who depend entirely on their pacemaker. Overall, remote monitoring can improve healthcare outcomes and make heart care more efficient. ^{2 3 4 5 6}

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 patients with a Medtronic or Abbott pacemaker that can be remotely monitored. Participants must be able to give consent and have access to a smartphone or tablet. It's not for those without a family doctor or if their device doesn't reliably adjust pacing in pacemaker-dependent patients.

Inclusion Criteria

Patients with a Medtronic or Abbott pacemaker capable of remote monitoring

Able to provide consent

Access to a Smartphone or Tablet

Exclusion Criteria

No access to a family physician or general practitioner

Unreliable autocapture function by device in pacemaker dependent patients

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Initial Implant and Optimization

Newly implanted pacemaker patients will be seen after the initial implant at the hub site, within 48 hours and then within 3 months to optimize programming for subsequent remote monitoring visits.

3 months

2 visits (in-person)

Remote Monitoring

Patients will be followed by remote monitoring only. Transmissions will occur at six monthly intervals, with no routine in-clinic visits unless an actionable event occurs.

18 months

Remote transmissions every 6 months

Follow-up

Participants are monitored for safety and effectiveness after treatment, including assessment of major adverse cardiac events and quality of life measures.

18 months

What Are the Treatments Tested in This Trial?

Interventions

• Remote Monitoring

Trial Overview The study is testing the effectiveness of remote monitoring (RM) technology for managing cardiac implantable electronic devices (CIEDs), specifically pacemakers, compared to standard care. The goal is to follow up safely and cost-effectively using CANet's patient-centered platform.

How Is the Trial Designed?

Group I: Remote Patient Management Active Control 1 Intervention

Remote monitoring only

Group II: Standard of Care Placebo Group 1 Intervention

In-clinic visits

Remote Monitoring is already approved in European Union, United States, Canada for the following indications:

Approved in European Union as Remote Monitoring for:

• Cardiac Implantable Electronic Devices (CIEDs) management
• Implantable Cardioverter Defibrillator (ICD) monitoring
• Pacemaker (PM) surveillance

Approved in United States as Remote Monitoring for:

• CIEDs management
• ICD monitoring
• PM surveillance

Approved in Canada as Remote Monitoring for:

• CIEDs management
• ICD monitoring
• PM surveillance (limited use)

Who Is Running the Clinical Trial?

Ratika Parkash

Lead Sponsor

Trials

5

Recruited

2,400+

Cardiac Arrhythmia Network of Canada

Collaborator

Trials

14

Recruited

8,400+

Medtronic

Industry Sponsor

Trials

627

Recruited

767,000+

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

Abbott

Industry Sponsor

Trials

760

Recruited

489,000+

Dr. Etahn Korngold

Abbott

Chief Medical Officer

MD, Harvard Medical School

Robert B. Ford

Abbott

Chief Executive Officer since 2020

Bachelor's degree from Boston College, MBA from UC Berkeley, Haas School of Business

Published Research Related to This Trial

The RM-ALONE trial, involving 445 patients with pacemakers and implantable cardiac defibrillators, demonstrated that remote monitoring (RM) alone is as safe as traditional in-office evaluations, with similar rates of major adverse cardiac events (MACE) between the two groups.

Implementing a home monitoring-only approach significantly reduced the need for in-office evaluations by 79.2%, while also decreasing the time healthcare providers spent per patient, indicating a more efficient surveillance method for cardiac devices.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety and efficiency of a common and simplified protocol for pacemaker and defibrillator surveillance based on remote monitoring only: a long-term randomized trial (RM-ALONE). García-Fernández, FJ., Osca Asensi, J., Romero, R., et al.[2020]

The RAPID study is investigating the effectiveness of Remote Monitoring (RM) for detecting high atrial rate episodes (AHREs) in 98 pacemaker recipients over 18 months, comparing outcomes between those monitored remotely and those receiving traditional in-hospital follow-ups.

This study aims to determine if RM can lead to faster medical intervention for AHREs, potentially improving patient outcomes compared to conventional monitoring methods.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Remote Monitoring of Atrial High Rate Episodes in Pacemaker Patients. The Rapid Study Design. Russo, V., Rago, A., Tavoletta, V., et al.[2022]

Implementing Lean Six Sigma methods to improve patient education and clinic design led to a 194% increase in remote monitoring (RM) enrolment for patients with cardiac devices, significantly enhancing patient follow-up.

The changes resulted in a 70% decrease in unscheduled clinic attendances, indicating that RM not only streamlined patient management but also improved the quality of care by allowing for safer and more timely responses to cardiac events.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Enhancing efficiency in a cardiac investigations department by increasing remote patient monitoring. Ryan, P., McGrath, C., Lawrie, I., et al.[2021]

Remote Monitoring (RM) significantly reduces the need for in-office visits by allowing for optimal management of pacing devices, enabling rapid diagnosis of device or lead failures, and shortening the response time to adverse events.

RM can detect arrhythmias 1 to 5 months earlier than traditional in-office visits and has potential in predicting worsening heart failure outcomes, suggesting it could improve clinical outcomes and survival rates in heart failure patients, although its use remains debated.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Remote monitoring: Doomed to let down or an attractive promise? Lucà, F., Cipolletta, L., Di Fusco, SA., et al.[2021]

A study of 269,471 patients with various cardiac devices showed that remote monitoring (RM) is linked to improved survival rates, with higher adherence to RM correlating with better outcomes.

Patients using RM for 75% or more of the time had a 2.10 times higher survival rate compared to those who never used RM, indicating that consistent use of this technology can significantly enhance patient health outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Relationship Between Level of Adherence to Automatic Wireless Remote Monitoring and Survival in Pacemaker and Defibrillator Patients. Varma, N., Piccini, JP., Snell, J., et al.[2022]

Remote monitoring (RM) of pacemakers is associated with higher rates of atrial tachyarrhythmia (ATA) detection and fewer in-office visits per patient per year compared to conventional monitoring (CM), based on a systematic review of 8 randomized controlled trials involving 4063 patients.

There were no significant differences in all-cause mortality, stroke, hospitalizations for cardiovascular events, or quality of life between RM and CM, indicating that RM does not compromise patient safety.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Long-Term Remote vs. Conventional Monitoring of Pacemakers: Systematic Review and Meta-Analysis of Randomized Controlled Trials. Menezes Junior, AS., Rivera, A., Ayumi Miyawaki, I., et al.[2023]

Remote monitoring (RM) for implanted pacemakers and defibrillators allows healthcare professionals to access patient data without requiring in-person visits, which can lead to faster identification of clinical issues and device problems.

The position statement advocates for RM to be a standard part of care in all device follow-up clinics, emphasizing the need for proper design and implementation to protect patient rights and health information.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Canadian Cardiovascular Society/Canadian Heart Rhythm Society joint position statement on the use of remote monitoring for cardiovascular implantable electronic device follow-up. Yee, R., Verma, A., Beardsall, M., et al.[2022]

In a study involving over 9,000 matched patients, smartphone-based remote monitoring (SM-RM) showed significantly higher compliance rates (94.4%) compared to traditional bedside monitoring (BM-RM) at 85.0%, indicating that patients are more likely to engage with their health using smartphone technology.

Patients using SM-RM also demonstrated better connectivity, transmitting data more frequently (every 1.2 days) than those using BM-RM (every 1.7 days), which suggests that smartphone applications may enhance ongoing patient monitoring and engagement.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Smartphone-based cardiac implantable electronic device remote monitoring: improved compliance and connectivity. Manyam, H., Burri, H., Casado-Arroyo, R., et al.[2023]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10522456/

Patient Outcomes Associated with the First Remote ... The study participants were satisfied with their first remote monitoring experience and reported having time- and cost-savings by using remote monitoring.

2. heartrhythmopen.com heartrhythmopen.com/article/S2666-5018(25)00286-7/fulltext

Outcomes associated with remote monitoring without in- ... A remote-first CIED care model may improve device clinic efficiency and reduce potentially low-value visits for patients actively engaged in RM.

3. heartrhythmjournal.com heartrhythmjournal.com/article/S1547-5271(25)02717-1/fulltext

Management of clinical issues detected through remote ... Management of clinical issues detected through remote monitoring of cardiac implantable electronic devices: Recommendations from a Delphi ...

4. academic.oup.com academic.oup.com/europace/article/25/9/euad233/7248717

Remote monitoring of cardiac implantable electronic devices ... Remote monitoring has the potential of impacting patient outcome by early detection and continuous monitoring of AF. Evidence of these benefits ...

5. ahajournals.org ahajournals.org/doi/10.1161/CIRCEP.124.013078

Sane Approach to Optimizing the Workload in Remote ... Remote monitoring offers an effective and safe method for monitoring patients with cardiovascular implantable electronic devices.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10451003/

Remote monitoring of cardiac implantable electronic devices ... Remote monitoring has the potential of impacting patient outcome by early detection and continuous monitoring of AF. Evidence of these benefits ...