Alert-Based Care for Pacemaker Patients
(RAPTOR - MAIN Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
he Remote Alert Pathway to Optimize Care of Cardiac Implantable Electrical Devices (RAPTOR-CIED) Study is a pragmatic, multi-center, randomized trial with 1:1 patient-level randomization comparing the safety and effectiveness of alert-driven care versus guideline-based care for patients with wireless cardiac implantable electrical devices (CIEDs).
The study will be conducted in 2 phases: a Feasibility Phase and a Main Phase. This registration outlines the goals and design features of the Main Phase of the study.
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
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Main Phase
Participants are randomized to either alert-driven care or guideline-based care for management of cardiac implantable electrical devices
Follow-up
Participants are monitored for safety and effectiveness after the main phase
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
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
Alert-based care is an alternative strategy for longitudinal management of patients with wireless pacemakers and implantable defibrillators
Find a Clinic Near You
Who Is Running the Clinical Trial?
Beth Israel Deaconess Medical Center
Lead Sponsor
Patient-Centered Outcomes Research Institute
Collaborator
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