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

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. ^{1 2 3 4 5}

Why 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. ^{2 3 6 7 8}

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

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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) 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]

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]

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]

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]

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]

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]

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]

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]

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Using Remote Patient Monitoring Technologies for Better ...

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Remote Patient Management for Cardiac Arrhythmias

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 ...

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pmc.ncbi.nlm.nih.gov

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The majority of cardiologists would be more likely to use RPM if the devices were medical-grade (86%), if there was EHR interoperability. (86%), if RPM data ...