Remote Alert Pathway To Optimize CaRe of Cardiac Implantable Electrical Devices

NCT06937658 | Recruiting DMC FDA Device

• 1 other identifier: PLACER-2023C3-34968
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (2)

• Enrollment

  Number of patients enrolled and randomized per site and per month, and cumulatively

  6 months

• Adherence

  Proportion of cross-over

  6 months

Secondary Outcomes (9)

• Major adverse cardiac events

  6 months

• Major adverse cardiac events

  6 months

• Effectiveness

  6 months

• Effectiveness

  6 months

• Connectivity

  6 months

Study Arms (2)

Guideline-based Care

ACTIVE COMPARATOR

Remote monitoring programming scheduled for alert transmissions, patient-initiated transmissions, and routine transmissions (scheduled to occur every 90 days from the date of enrollment in the study); in-office interrogations on at least an annual basis

Device: Guideline-based care

Alert-based Care

ACTIVE COMPARATOR

Remote monitoring programming scheduled for alert transmissions and patient-initiated transmissions only

Device: Alert-based care

Interventions

Alert-based care DEVICE

Alert-based care is an alternative strategy for longitudinal management of patients with wireless pacemakers and implantable defibrillators

Alert-based Care

Guideline-based care DEVICE

Guideline-based care is the current typical standard for longitudinal management of patients with wireless pacemakers and implantable defibrillators

Guideline-based Care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Beth Israel Deaconess Medical Center: lead
• Patient-Centered Outcomes Research Institute: collaborator

Study Sites (1)

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

RECRUITING

Central Study Contacts

Linda Valsdottir, MS

CONTACT

6176678800; lvalsdot@bidmc.harvard.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Medicine

Study Record Dates

• First Submitted: April 8, 2025
• First Posted: April 22, 2025
• Study Start: May 1, 2025
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): June 30, 2026
• Last Updated: January 7, 2026

Record last verified: 2026-01

Locations

US (1)