Remote Alert Pathway To Optimize CaRe of Cardiac Implantable Electrical Devices

Not Applicable

Not yet recruiting

• Conditions: Pacemaker DDD; Implantable Defibrillator User

• Registration Number: NCT06937658
• Lead Sponsor: Beth Israel Deaconess Medical Center

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-04
• Study First Submitted: 2025-04-08
• Study First Submitted QC: 2025-04-18
• Last Update Submitted: 2025-04-18
• Study First Posted: 2025-04-22
• Last Update Posted: 2025-04-22
• Study Start: 2025-05-01
• Primary Completion: 2026-06-30
• Study Completion: 2026-06-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

1. Adult aged > 18 years
2. Clinically stable by investigator assessment
3. 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)
4. 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
5. Currently enrolled in remote monitoring as part of standard of care
6. Primary clinical electrophysiology follow-up at the enrolling center
7. Understands spoken and written English, Spanish, or Portuguese
8. Has sufficient cognitive function to answer standardized questions about study rationale and procedures.

Exclusion Criteria

1. Presence of insertable cardiac monitor, either in isolation or in combination with any other CIED
2. Listed for cardiac transplantation prior to enrollment (N.B. if a patient becomes listed for transplantation during the study, they may continue study participation)
3. Participation in another study related to novel CIED technology or remote monitoring.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Enrollment	6 months	Number of patients enrolled and randomized per site and per month, and cumulatively
Adherence	6 months	Proportion of cross-over

Secondary Outcome Measures

Name	Time	Method
Major adverse cardiac events	6 months	Incidence of arrhythmia events, individual components of MACE, and health services use (i.e., hospital presentations)
Effectiveness	6 months	Proportion of total device related encounters that are actionable (e.g., changes in programming or treatment)
Connectivity	6 months	• Proportion of 24-, 48-, and 72-hour periods with versus without connected wireless monitoring
Quality of Life and Health Status	Baseline, 3 months, and 6 months	Patient Activation Measure (PAM) - scored from 0 to 100, with a higher score indicating better outcomes

Trial Locations

Locations (1)

Beth Israel Deaconess Medical Center; 🇺🇸 Boston, Massachusetts, United States