Remote Alert Pathway To Optimize CaRe of Cardiac Implantable Electrical Devices
Trial Parameters
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
Brief Summary
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 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 Feasibility Phase of the study.
Eligibility Criteria
Inclusion Criteria: 1. Adult aged \> 18 years 2. Clinically stable by investigator assessment 3. 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) 4. 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 5. Currently enrolled in remote monitoring as part of standard of care 6. Primary clinical electrophysiology follow-up at the enrolling center 7. Understands spoken and written English, Spanish, or Portuguese 8. Has sufficient cognitive function to answer standardized questions about study rationale and procedures. Exclusion Criteria: 1. Presence of insertable cardiac monitor, either in isolation or in combination with any other CIED 2. Listed for cardiac transplantation prior to enrollment (N.B. if a patient becomes listed f