Remote Alert Pathway To Optimize CaRe of Cardiac Implantable Electrical Devices

Launched by BETH ISRAEL DEACONESS MEDICAL CENTER · Apr 18, 2025

Keywords

ClinConnect Summary

The RAPTOR-CIED Study is looking at how to improve care for patients with wireless cardiac devices, like pacemakers and implantable defibrillators. This clinical trial will compare two approaches: one where doctors respond to alerts from these devices, and another where care follows standard guidelines. The goal is to see which method is safer and more effective for managing heart health in patients who have these devices.

To participate, you need to be an adult over 18 years old, in stable health, and have a wireless cardiac device from one of the major manufacturers. You should also be receiving remote monitoring as part of your regular care and be able to understand English, Spanish, or Portuguese. If you join the study, you can expect to have your heart health monitored closely and receive care tailored to your needs based on the study's findings. Remember, this trial is not yet recruiting participants, but it aims to help improve future care for people with cardiac devices.

Gender

ALL

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 for transplantation during the study, they may continue study participation)
• • 3. Participation in another study related to novel CIED technology or remote monitoring.