Alert-Based Care for Cardiac Device Management

(RAPTOR-CIED Trial)

Overseen By Linda Valsdottir, MS

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Beth Israel Deaconess Medical Center

Disqualifiers: Cardiac monitor, Transplantation, Other study

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 90

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores the effectiveness of alert-driven care compared to guideline-based care for individuals with wireless cardiac implantable devices, such as pacemakers or defibrillators. The goal is to determine which method better supports heart health through remote monitoring. Individuals with a wireless heart device from a major manufacturer who are already using remote monitoring may be suitable candidates.

As an unphased trial, this study provides an opportunity for patients to contribute to innovative research that could improve heart health management for many.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It is best to discuss this with the study team or your doctor.

What prior data suggests that this alert-based care is safe for cardiac device management?

Research has shown that remote monitoring for heart devices is safe and well-received. Many studies have found that this method can streamline clinic operations and reduce unnecessary visits, enhancing patient comfort and convenience. It is the standard care for individuals with devices like pacemakers, indicating a strong safety record. Both patients and doctors generally find remote monitoring effective. Overall, these findings support the safety of using alert-based care for managing heart devices. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores how different monitoring techniques can improve the management of cardiac devices. Unlike the standard guideline-based care, which involves regular in-office check-ups and scheduled remote monitoring every 90 days, alert-based care focuses solely on alert and patient-initiated transmissions. This approach could make cardiac care more efficient by reducing the need for routine check-ins and potentially offering a faster response to patient issues. By streamlining the monitoring process, alert-based care might provide patients with more timely interventions and reduce the burden of frequent appointments.

What evidence suggests that this trial's treatments could be effective for cardiac device management?

This trial will compare two approaches: Alert-based Care and Guideline-based Care for managing cardiac devices. Research has shown that using alerts to manage heart devices can be effective. Studies have found that patients using remote monitoring after receiving a heart device often live longer. This method helps heart clinics operate more smoothly and reduces unnecessary visits. Experts agree that remote monitoring lowers health risks in managing these devices. Overall, this approach provides a safe and efficient way to care for patients with heart devices. ^{1 2 3 5 6}

Are You a Good Fit for This Trial?

The RAPTOR-CIED study is for individuals with wireless dual chamber pacemakers or ICDs. Specific eligibility criteria are not provided, but typically participants must meet certain health conditions and agree to follow the study procedures.

Inclusion Criteria

Has a newly implanted or existing wireless CIED: single, dual-chamber, biventricular, subcutaneous/extravascular, and leadless systems are all eligible, including pacemakers or implantable cardioverter-defibrillators (ICDs)

I am older than 18 years.

Clinically stable by investigator assessment

Exclusion Criteria

Presence of insertable cardiac monitor, either in isolation or in combination with any other CIED

Listed for cardiac transplantation prior to enrollment (N.B. if a patient becomes listed for transplantation during the study, they may continue study participation)

Participation in another study related to novel CIED technology or remote monitoring.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Feasibility Phase

Initial phase to assess the feasibility of alert-driven care versus guideline-based care for patients with CIEDs

6 months

Remote monitoring with scheduled transmissions every 90 days

Main Phase

Main phase to evaluate the safety and effectiveness of alert-driven care versus guideline-based care

6 months

Remote monitoring with patient-initiated and alert transmissions

Follow-up

Participants are monitored for safety and effectiveness after the main phase

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Alert-based care
• Guideline-based care

Trial Overview This trial compares two types of care for patients with cardiac devices: alert-driven care where doctors respond to alerts from the device, and guideline-based care that follows standard medical guidelines. It's a randomized trial meaning people are put into groups by chance.

How Is the Trial Designed?

Group I: Guideline-based Care Active Control 1 Intervention

Remote monitoring programming scheduled for alert transmissions, patient-initiated transmissions, and routine transmissions (scheduled to occur every 90 days from the date of enrollment in the study); in-office interrogations on at least an annual basis

Group II: Alert-based Care Active Control 1 Intervention

Remote monitoring programming scheduled for alert transmissions and patient-initiated transmissions only

Who Is Running the Clinical Trial?

Beth Israel Deaconess Medical Center

Lead Sponsor

Trials

872

Recruited

12,930,000+

Patient-Centered Outcomes Research Institute

Collaborator

Trials

592

Recruited

27,110,000+

Published Research Related to This Trial

In a study analyzing 1012 medication regimens in a nephrology clinic, more specific alerting strategies significantly reduced the number of alerts generated, with the most advanced strategy (D) resulting in alerts for only 7.81% of regimens compared to 87.5% with the least specific strategy (A).

The findings suggest that using patient and drug-specific information in alert systems can effectively minimize alert fatigue among physicians, potentially improving the safety of prescribing medications to patients with renal impairment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Tailoring of alerts substantially reduces the alert burden in computerized clinical decision support for drugs that should be avoided in patients with renal disease. Czock, D., Konias, M., Seidling, HM., et al.[2017]

Opioid alerts in clinical decision support systems were overridden 96.3% of the time, indicating a high override rate compared to non-opioid alerts, which raises concerns about alert fatigue among healthcare providers.

Despite the high override rates, only 0.31% of patients experienced adverse drug events related to opioids, and none of these events were preventable by the alerts, suggesting that while alerts can avert some adverse events, the system generates many unnecessary alerts that could hinder patient safety.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinically Inconsequential Alerts: The Characteristics of Opioid Drug Alerts and Their Utility in Preventing Adverse Drug Events in the Emergency Department. Genco, EK., Forster, JE., Flaten, H., et al.[2018]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11990655/

Patient and Clinician Perspectives on Alert-Based Remote ... Improved survival in patients enrolled promptly into remote monitoring following cardiac implantable electronic device implantation. J ...

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(23)02011-8/fulltext

2023 HRS/EHRA/APHRS/LAHRS expert consensus ... Remote monitoring is beneficial for the management of patients with cardiovascular implantable electronic devices by impacting morbidity and ...

4. 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.

5. sciencedirect.com sciencedirect.com/science/article/pii/S2666501825002867

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.

6. 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 ...