Remote alert pathway to improve care for pacemaker and ICD users

Remote Alert Pathway To Optimize CaRe of Cardiac Implantable Electrical Devices

This trial will test whether using an alert-driven care pathway leads to safer and more effective follow-up than standard guideline-based care for adults with wireless pacemakers or implantable defibrillators.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 120 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Beth Israel Deaconess Medical Center (Academic / other)
• Locations: 1 site (Boston, Massachusetts)
• Trial ID: NCT06937658 on ClinicalTrials.gov

What this trial studies

RAPTOR-CIED is a pragmatic, multicenter, randomized 1:1 trial comparing alert-driven care versus guideline-based care for patients with wireless cardiac implantable electrical devices (CIEDs). The program includes a Feasibility Phase followed by a Main Phase, and this registration describes the Feasibility Phase design and goals. Eligible participants are adults with wireless pacemakers or ICDs from the four major US manufacturers who are already enrolled in remote monitoring and receive primary electrophysiology follow-up at the enrolling center. The trial will measure safety and effectiveness outcomes related to device alerts, clinical responses, and care processes.

Who should consider this trial

Good fit: Adults over 18 who are clinically stable, have a wireless CIED from Medtronic, Boston Scientific, Abbott, or Biotronik, are enrolled in remote monitoring, receive primary electrophysiology follow-up at the enrolling center, and can communicate in English, Spanish, or Portuguese are ideal candidates.

Not a fit: Patients with an insertable cardiac monitor, those listed for cardiac transplant prior to enrollment, those not enrolled in remote monitoring, or those not followed at the enrolling center are unlikely to receive benefit from this protocol.

Why it matters

Potential benefit: If successful, the alert-driven pathway could speed responses to important device alerts and reduce device-related complications and unnecessary clinic visits.

How similar studies have performed: Prior research has shown that remote monitoring can detect events earlier and improve workflow, but randomized comparisons of alert-driven care versus guideline-based care are limited.

Eligibility criteria

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.

Where this trial is running

Boston, Massachusetts

• Beth Israel Deaconess Medical Center — Boston, Massachusetts, United States (Recruiting)

Study contacts

• Study coordinator: Linda Valsdottir, MS

Conditions Pacemaker DDD; Implantable Defibrillator User