Actively Recruiting
Remote Alert Pathway To Optimize CaRe of Cardiac Implantable Electrical Devices
Led by Beth Israel Deaconess Medical Center · Updated on 2026-01-07
120
Participants Needed
1
Research Sites
60 weeks
Total Duration
On this page
Sponsors
B
Beth Israel Deaconess Medical Center
Lead Sponsor
P
Patient-Centered Outcomes Research Institute
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Remote Alert Pathway To Optimize CaRe of Cardiac Implantable Electrical Devices
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adult aged > 18 years
- Clinically stable by investigator assessment
- Has a newly implanted or existing wireless cardiac implantable electrical device (CIED), including single, dual-chamber, biventricular, subcutaneous/extravascular, and leadless pacemakers or implantable cardioverter-defibrillators (ICDs)
- CIED is from one of the 4 major manufacturers in the US market (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
You will not qualify if you...
- Presence of insertable cardiac monitor, either alone or combined with any other CIED
- Listed for cardiac transplantation prior to enrollment (may continue if listed during the study)
- Participation in another study related to novel CIED technology or remote monitoring
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02215
Actively Recruiting
Research Team
L
Linda Valsdottir, MS
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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