Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT06937658

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

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

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
Not Eligible

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

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Trial Site Locations

Total: 1 location

1

Beth Israel Deaconess Medical Center

Boston, Massachusetts, United States, 02215

Actively Recruiting

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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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