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Completed NCT06937658

Remote Alert Pathway To Optimize CaRe of Cardiac Implantable Electrical Devices

Conditions: Pacemaker DDD, Implantable Defibrillator User

Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: NA
Enrollment: 120
Sponsor: Beth Israel Deaconess Medical Center

Location: Beth Israel Deaconess Medical Center Boston Massachusetts

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

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT06937658). StuddyBuddy aggregates publicly available trial information.