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.
Adult aged > 18 years
Clinically stable by investigator assessment
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)
CIED is from one of the 4 major CIED manufacturers in the US market (99% of implants in the US): Medtronic, Boston Scientific, Abbott, Biotronik
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.
Parallel
Alert-based care
Other interventionAlert-based care is an alternative strategy for longitudinal management of patients with wireless pacemakers and implantable defibrillators
Guideline-based Care
Other interventionRemote 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
Major adverse cardiac events
Incidence of MACE (i.e., death, stroke or systemic embolism, and unplanned cardiac device procedure)
Effectiveness
Proportion of total device related encounters that are actionable (e.g., changes in programming or treatment)
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Beth Israel Deaconess Medical Center
Lead sponsor
Patient-Centered Outcomes Research Institute
Collaborator
This trial is not recruiting at the moment. You can still explore other options:
