Remote Monitoring for Pacemaker Management

(RPM CIED Brady Trial)

Recruiting at 10 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

Trial Summary

What is the purpose of this trial?

While remote monitoring (RM) technology is currently available and has permitted surveillance and device assessment from any patient location, the use has been inconsistent in Canada, where only 8500 out of a potential 120 000 patients with cardiac implantable electronic devices (CIEDs) are enrolled in this program. This technology is in widespread use worldwide for all CIEDs but in Canada, it is utilized primarily for implantable defibrillators, but not pacemakers. Whereas most of the trials were designed to evaluate the efficacy of RM in implantable cardioverter defibrillator (ICD) patients, in the pacemaker (PM) population, there has been work performed already to demonstrate an increase in detection of frequency of adverse clinical events and a reduction in reaction time to those events by RM. Based on all the available literature, it appears that RM benefits both patients and healthcare systems. Overall, studies have demonstrated that RM can be used safely in all device patient-populations, with the exception of pacemaker-dependent patients. There have been no studies that have evaluated RM only follow up, nor have there been any studies evaluating pacemaker-dependent patients. This study that will safely assess the use of RM only, with in-clinic visits when necessary, that uses the patient-centered electronic platform developed by the Cardiac Arrhythmia Network of Canada (CANet) to perform PM follow up safely, in a more cost-effective manner.

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 data supports the effectiveness of the treatment Remote Monitoring for Pacemaker Management?

Research shows that remote monitoring (RM) for pacemakers can speed up the detection of clinical events and device issues, reduce the need for in-office visits, and improve patient outcomes by allowing healthcare professionals to quickly respond to problems. RM has been associated with safer and higher quality care, and it can detect heart rhythm issues months earlier than traditional methods. ^{1 2 3 4 5}

Is remote monitoring for pacemakers safe?

Remote monitoring for pacemakers is generally considered safe and is recommended as part of standard care for patients with these devices. It allows for continuous monitoring and early detection of issues, which can lead to prompt medical intervention. ^{1 5 6 7 8}

How is the treatment Remote Monitoring for Pacemaker Management different from other treatments?

Remote Monitoring for Pacemaker Management is unique because it allows pacemakers to send diagnostic information directly to healthcare professionals without the patient needing to visit a clinic. This technology can quickly identify clinical events and device issues, potentially improving patient outcomes and reducing the need for in-office visits. ^{1 2 5 6 7}

Research Team

Ratika Parkash, MD FRCPC

Principal Investigator

Nova Scotia Health Authority

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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

Findings from Research

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]

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]

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]

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]

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]

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]

References

1. England 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. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

Long-Term Remote vs. Conventional Monitoring of Pacemakers: Systematic Review and Meta-Analysis of Randomized Controlled Trials. [2023]

3. England pubmed.ncbi.nlm.nih.gov

Enhancing efficiency in a cardiac investigations department by increasing remote patient monitoring. [2021]

4. Ireland pubmed.ncbi.nlm.nih.gov

Remote monitoring: Doomed to let down or an attractive promise? [2021]

5. United States pubmed.ncbi.nlm.nih.gov

The Relationship Between Level of Adherence to Automatic Wireless Remote Monitoring and Survival in Pacemaker and Defibrillator Patients. [2022]

6. United States pubmed.ncbi.nlm.nih.gov

Remote Monitoring of Atrial High Rate Episodes in Pacemaker Patients. The Rapid Study Design. [2022]

7. England pubmed.ncbi.nlm.nih.gov

Smartphone-based cardiac implantable electronic device remote monitoring: improved compliance and connectivity. [2023]

8. England 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). [2020]