RecruitingNot Applicable

Remote Alert Pathway To Optimize CaRe of Cardiac Implantable Electrical Devices

United States120 participantsStarted 2025-05-01

Plain-language 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.

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓. 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
✓. Currently enrolled in remote monitoring as part of standard of care
✓. Primary clinical electrophysiology follow-up at the enrolling center
✓. Understands spoken and written English, Spanish, or Portuguese
✓. Has sufficient cognitive function to answer standardized questions about study rationale and procedures.

Exclusion criteria

✕. 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.

What they're measuring

Enrollment

Timeframe: 6 months

Adherence

Timeframe: 6 months

Trial details

NCT IDNCT06937658

SponsorBeth Israel Deaconess Medical Center

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-06-30

Contact for this trial

Linda Valsdottir, MS

6176678800 lvalsdot@bidmc.harvard.edu

View on ClinicalTrials.gov More Pacemaker DDD trials