Alert-Based Care for Pacemaker Patients

(RAPTOR - MAIN Trial)

DB
Overseen ByDaniel B Kramer, MD, MPH
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Beth Israel Deaconess Medical Center
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines the effectiveness of two care approaches for individuals with pacemakers or defibrillators. Alert-based Care uses alerts to guide treatment, while Guideline-based Care follows standard guidelines. The trial aims to determine which method is safer and more effective. It may suit individuals with a wireless pacemaker or defibrillator who already use remote monitoring as part of their regular care. As an unphased trial, it provides a unique opportunity to contribute to research that could enhance future care strategies.

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's best to discuss this with the study team or your doctor.

What prior data suggests that this alert-based care is safe for pacemaker patients?

Research has shown that using alerts to care for patients with pacemakers and defibrillators is generally safe. Studies have found that managing these devices through remote monitoring is effective and easy for patients to handle. For instance, a remote-first care model can streamline clinic operations and reduce unnecessary visits, indicating that patients usually encounter few problems with this method.

Another study pointed out that remote monitoring is a safe way to track patients with these devices. Both patients and doctors find this method efficient and easy to use, making it a dependable choice for ongoing care. Overall, based on the available data, alert-based care appears to be a safe option for managing pacemakers and defibrillators.12345

Why are researchers excited about this trial?

Researchers are excited about the trial of alert-based care for pacemaker patients because it offers a more tailored approach to managing heart devices. Unlike the traditional guideline-based care, which relies on routine transmissions and scheduled in-office check-ups, alert-based care focuses on real-time monitoring and management through wireless alerts. This proactive strategy could lead to earlier detection of issues and personalized treatment, potentially improving patient outcomes and reducing the need for frequent office visits.

What evidence suggests that this trial's treatments could be effective for pacemaker patients?

This trial will compare Alert-based Care with Guideline-based Care for patients with wireless heart devices. Research has shown that using alerts to care for these patients appears promising. Remote monitoring, a key component of alert-based care, has proven effective and safe for tracking patients with devices like pacemakers and defibrillators. An international study found that 94.6% of scheduled data transmissions succeeded, indicating strong reliability. This approach may also enhance device clinic efficiency by reducing unnecessary visits. Although more information is needed, early findings suggest that alert-based care could improve management for patients with heart devices.12467

Are You a Good Fit for This Trial?

The RAPTOR-CIED Study is for adults over 18 with a wireless cardiac device like pacemakers or defibrillators. They must be clinically stable, have devices from major US manufacturers, enrolled in remote monitoring, and followed up at the study center. Understanding English, Spanish, or Portuguese and being able to comprehend the study are also required.

Inclusion Criteria

I have a pacemaker or defibrillator implanted.
My cardiac device is made by Medtronic, Boston Scientific, Abbott, or Biotronik.
I am enrolled in a remote monitoring program as part of my treatment.
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Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Main Phase

Participants are randomized to either alert-driven care or guideline-based care for management of cardiac implantable electrical devices

2 years
Routine transmissions every 90 days, annual in-office interrogations

Follow-up

Participants are monitored for safety and effectiveness after the main phase

4-8 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 signals from the device versus standard guideline-based care. It's randomized so patients have equal chances of being in either group.

How Is the Trial Designed?

2

Treatment groups

Active Control

Group I: Guideline-based CareActive Control1 Intervention
Group II: Alert-based careActive Control1 Intervention

Find a Clinic Near You

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+

Citations

Patient and Clinician Perspectives on Alert-Based Remote ...

Remote monitoring (RM) is the standard of care for patients with cardiovascular implantable electronic devices (CIED; pacemaker or implantable ...

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.

Outcomes associated with remote monitoring without in- ...

A recent study assessed patient and clinician perspectives on alert-based RM-first care strategies, but these outcomes should be evaluated prospectively in ...

Sane Approach to Optimizing the Workload in Remote ...

Remote monitoring offers an effective and safe method for monitoring patients with cardiovascular implantable electronic devices.

App-Based Remote Monitoring of Pacemakers Boosts ...

International study finds 94.6% success for scheduled transmissions, good patient acceptance. Pacemaker x-ray.

Remote Alert Pathway To Optimize CaRe of Cardiac ...

The Remote Alert Pathway to Optimize Care of Cardiac Implantable Electrical Devices (RAPTOR-CIED) Study is a pragmatic, multi-center, randomized trial with 1:1 ...

Remote monitoring of pacemakers and defibrillators

This study evaluated consecutive 119 patients: 30.2% with pacemakers, 42.8% with implantable cardioverter-defibrillator, 22.7% with cardiac resynchronization ...