Remote Alert Pathway To Optimize CaRe of Cardiac Implantable Electrical Devices
NCT06937658 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 120
Last updated 2026-01-07
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.
Conditions
- Pacemaker DDD
- Implantable Defibrillator User
Interventions
- DEVICE
-
Alert-based care
Alert-based care is an alternative strategy for longitudinal management of patients with wireless pacemakers and implantable defibrillators
- DEVICE
-
Guideline-based care
Guideline-based care is the current typical standard for longitudinal management of patients with wireless pacemakers and implantable defibrillators
Sponsors & Collaborators
-
Patient-Centered Outcomes Research Institute
collaborator OTHER -
Beth Israel Deaconess Medical Center
lead OTHER
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- SINGLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2025-05-01
- Primary Completion
- 2026-06-30
- Completion
- 2026-06-30
- FDA Device
- Yes
Countries
- United States
Study Locations
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