Remote Patient Management for Cardiac Arrhythmias

(RPM CIED Tachy Trial)

Recruiting at 11 trial locations

Overseen By Patricia Theoret

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Ratika Parkash

Disqualifiers: No family physician, others

Compensation: Varies

Number of Visits: 6

1164 Participants Needed

Trial Summary

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 Patient Management for Cardiac Arrhythmias?

Research shows that remote patient monitoring (RPM) can be as effective as in-clinic visits for managing implantable cardioverter defibrillators (ICDs) and has improved outcomes in chronic heart failure patients by enabling early detection and prevention of health deterioration. ^{1 2 3 4 5}

Is remote patient monitoring generally safe for humans?

The research does not provide specific safety data for remote patient monitoring, but it is widely used for managing chronic diseases and improving care, suggesting it is generally considered safe. ^{1 2 5 6 7}

How is the Remote Patient Management treatment for cardiac arrhythmias different from other treatments?

Remote Patient Management (RPM) for cardiac arrhythmias is unique because it allows continuous monitoring of patients' heart conditions from their homes using technology, which can lead to better management and outcomes compared to traditional in-person visits. This approach can improve patient satisfaction and engagement by providing care in a more convenient and comfortable setting. ^{1 2 5 8 9}

What is the purpose of this trial?

This is a Canadian multicenter randomized controlled trial to assess remote patient management. Patients will be randomized to remote patient management with VIRTUES versus usual care, and will be stratified by RemoteView vs no RemoteView utilization, as well as by center.

Research Team

Ratika Parkash, MD FRCPC

Principal Investigator

Nova Scotia Health Authority

Eligibility Criteria

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

Able to provide consent

You have a specific type of defibrillator from Medtronic or Abbott that can be monitored remotely using Carelink or Merlin.

Exclusion Criteria

No family physician

The device that helps your heart beat cannot be trusted to work properly on its own.

Participation in another randomized clinical trial

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Remote Patient Management

Participants are managed remotely using VIRTUES and Remote View technologies, avoiding travel to specialized clinics

18 months

Remote monitoring only

Standard of Care

Participants receive remote monitoring at 6-month intervals, alternating with yearly in-clinic visits

18 months

6-month remote monitoring, yearly in-clinic visits

Follow-up

Participants are monitored for safety and effectiveness after the main trial period

4 weeks

Treatment Details

Interventions

• Remote Patient Management
• Standard of Care

Trial Overview The study compares two approaches to managing cardiac arrhythmias: one group will use remote patient management tools, while the other will receive usual care without these tools. Participants are randomly assigned to groups, considering their current tech use and location.

Participant Groups

Group I: Remote Patient Management Active Control 1 Intervention

Patients will be followed by remote monitoring only.

Group II: Standard of Care Placebo Group 1 Intervention

Remote monitoring at 6 month intervals, alternating with yearly in-clinic visits at their usual site.

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

Approved in United States as Remote Patient Monitoring for:

• Cardiovascular disease management
• Chronic disease management
• Post-surgical recovery

Approved in European Union as Remote Patient Monitoring for:

• Heart failure management
• Atrial fibrillation detection
• Chronic kidney disease management

Approved in Canada as Remote Patient Monitoring for:

• Cardiovascular implantable electronic device management
• Chronic disease management

Who Is Running the Clinical Trial?

Ratika Parkash

Lead Sponsor

Trials

5

Recruited

2,400+

Abbott Medical Devices

Industry Sponsor

Trials

659

Recruited

420,000+

Founded

1888

Headquarters

Abbott Park, Illinois, USA

Known For

Medical Devices Innovation

Top Products

FreeStyle Libre, MitraClip, XIENCE Stents, TECNIS IOLs

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

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

Cardiac Arrhythmia Network of Canada

Collaborator

Trials

14

Recruited

8,400+

Findings from Research

A survey of 3172 patients enrolled in a remote patient monitoring (RPM) program showed that 88.97% felt comfortable managing their health from home, indicating high patient engagement and satisfaction with the program.

93.58% of participants expressed readiness to graduate from the RPM program after meeting their health goals, and 92.76% would recommend RPM to others, demonstrating the program's effectiveness in managing both acute and chronic conditions outside of traditional healthcare settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Patient Satisfaction With a Multisite, Multiregional Remote Patient Monitoring Program for Acute and Chronic Condition Management: Survey-Based Analysis. Haddad, TC., Maita, KC., Inselman, JW., et al.[2023]

The ETAPES funding program in France, initiated in 2016 and operational since 2018, supports remote patient monitoring (RPM) specifically for patients with chronic heart failure (CHF) who are at medium or high risk of re-hospitalization, emphasizing the importance of patient education and training in this model of care.

The Satelia® RPM solution focuses on symptomatic monitoring, allowing patients to report their health status through simple questionnaires rather than relying on connected devices, which may enhance patient engagement and ease of use.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Remote patient monitoring for chronic heart failure in France: When an innovative funding program (ETAPES) meets an innovative solution (Satelia® Cardio). Pages, N., Picard, F., Barritault, F., et al.[2022]

A study involving 1,538 heart failure patients over 12 months showed that remote patient management (RPM) led to high adherence rates (89.1%) for daily health measurements, indicating its effectiveness in monitoring patient health.

Patients reported high satisfaction with the RPM program, and adherence varied by age and location, suggesting that tailored approaches may be needed to maintain engagement, especially in younger patients and those in urban areas.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Patient reported experience and adherence to remote patient management in chronic heart failure patients: a posthoc analysis of the TIM-HF2 trial. Prescher, S., Winkler, S., Riehle, L., et al.[2023]

Remote patient monitoring (RPM) of implantable cardioverter defibrillators (ICDs) appears to be safe and effective, with trends indicating good patient satisfaction, although evidence from randomized trials on patient-reported outcomes is limited and inconclusive.

Future research, including the REMOTE-CIED study, aims to better understand the patient perspective on RPM, emphasizing the need for longer follow-up periods and validated measures to assess patient satisfaction and benefits.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The patient perspective on remote monitoring of patients with an implantable cardioverter defibrillator: Narrative review and future directions. Timmermans, I., Meine, M., Zitron, E., et al.[2018]

The Mayo Clinic's nurse-led remote patient monitoring (RPM) program has successfully supported nearly 22,000 patients, leading to significantly lower rates of hospitalization, ICU admissions, and mortality among those engaged with the program, particularly during the COVID-19 pandemic.

Patients with chronic conditions who utilized RPM after hospital discharge had a reduced likelihood of 30-day readmissions, demonstrating the program's efficacy in improving patient outcomes and satisfaction, with 95% of participants likely to recommend it to others.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Development and implementation of a nurse-based remote patient monitoring program for ambulatory disease management. Coffey, JD., Christopherson, LA., Williams, RD., et al.[2023]

Patients with hypertension at high-remote patient monitoring (RPM) practices experienced a 3.3% increase in medication fills and a 1.3% increase in unique medications received, indicating improved management of their condition.

Despite better medication management and fewer acute care encounters, patients at high-RPM practices had a $274 increase in total hypertension-related spending, suggesting that while RPM improves care, it may also lead to higher overall costs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of Remote Patient Monitoring Use on Care Outcomes Among Medicare Patients With Hypertension : An Observational Study. Tang, M., Nakamoto, CH., Stern, AD., et al.[2023]

Remote patient monitoring (RPM) can effectively identify early signs of COVID-19 infection in patients with chronic respiratory diseases, as demonstrated in three case reports involving 9 patients out of 1000 enrolled in a monitoring program.

The RPM system, which includes wearable health monitors and a smartphone app, detected physiological changes in patients at different stages of infection, allowing for earlier diagnosis and intervention, highlighting its potential for improving patient outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Early Identification of COVID-19 Infection Using Remote Cardiorespiratory Monitoring: Three Case Reports. Polsky, M., Moraveji, N.[2021]

Remote patient monitoring (RPM) is a practical tool for tracking physical activity in outpatient care, providing more reliable data than self-reports, as demonstrated in four pilot studies across various medical specialties.

RPM can enhance the management of chronic diseases and rehabilitation by offering clinicians objective feedback on patient progress, although attention must be given to ensure all populations can access these digital health services.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Implementing Remote Patient Monitoring of Physical Activity in Clinical Practice. McCarthy, M., Jevotovsky, D., Mann, D., et al.[2023]

Remote patient monitoring (RPM) for cardiac electrophysiological conditions, including the use of cardiac implantable electronic devices (CIEDs), has been shown to enhance care quality, increase patient satisfaction, and be cost-effective, as supported by various studies.

Recent advancements in RPM include the integration of wearable technologies, such as the Apple Watch, and the establishment of networks like the American College of Cardiology's digital transformation initiative, which aim to improve monitoring and management of cardiovascular diseases.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Digital Medicine and Evolution of Remote Patient Monitoring in Cardiac Electrophysiology: A State-of-the-Art Perspective. Atreja, A., Francis, S., Kurra, S., et al.[2020]

References

1. Canada pubmed.ncbi.nlm.nih.gov

Patient Satisfaction With a Multisite, Multiregional Remote Patient Monitoring Program for Acute and Chronic Condition Management: Survey-Based Analysis. [2023]

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

Remote patient monitoring for chronic heart failure in France: When an innovative funding program (ETAPES) meets an innovative solution (Satelia® Cardio). [2022]

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

Patient reported experience and adherence to remote patient management in chronic heart failure patients: a posthoc analysis of the TIM-HF2 trial. [2023]

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

The patient perspective on remote monitoring of patients with an implantable cardioverter defibrillator: Narrative review and future directions. [2018]

5. Switzerland pubmed.ncbi.nlm.nih.gov

Development and implementation of a nurse-based remote patient monitoring program for ambulatory disease management. [2023]

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

Effects of Remote Patient Monitoring Use on Care Outcomes Among Medicare Patients With Hypertension : An Observational Study. [2023]

7. Canada pubmed.ncbi.nlm.nih.gov

Early Identification of COVID-19 Infection Using Remote Cardiorespiratory Monitoring: Three Case Reports. [2021]

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

Implementing Remote Patient Monitoring of Physical Activity in Clinical Practice. [2023]

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

Digital Medicine and Evolution of Remote Patient Monitoring in Cardiac Electrophysiology: A State-of-the-Art Perspective. [2020]