IRB Study Number 25-321
Status Recruiting
Location J Building - Sydell and Arnold Miller Family Pavilion
Institute Heart and Vascular Institute
Description
The Remote Alert Pathway to Optimize Care of Cardiac Implantable Electrical Devices
(RAPTOR-CIED) Study is a pragmatic, multi-center, randomized trial 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. The purpose of the study evaluates patient feedback on CIED function and connectivity in the alert-driven transmissions, access safety of intervention i.e. the number of scheduled transmissions (every90 days) that are determined to be clinically important such as device malfunction, actionable events, and to assess quality of life and health status.
Participants enrolled in the Feasibility Phase will be followed by research staff for 6 months. Patients are randomized to one treatment group: a guideline-based care arm or an alert-driven care arm.
Patients randomized to the guideline-based care arm will have their 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).
Guideline-based care strategy includes patients scheduled
transmissions every 90 days (beginning once remote monitoring is initiated) with annual
in-office evaluation, in addition to alerts and patient-initiated transmissions.
Patients randomized to the alert-driven care arm will have their remote monitoring programming scheduled for alert transmissions and patient-initiated transmissions, but their routine transmissions (scheduled to occur every 90 days from the date of enrollment in the study) will be reviewed in a blinded fashion (patients/clinicians blinded) for clinical importance according to pre-specified criteria. In-office interrogations will not be scheduled unless there is a clinically driven rationale, e.g., need for a change in programming, interest in specific diagnostics, or any other clinical concern.
Alert-driven care is an alternative strategy to guideline-based care. Prior studies suggest that this approach to remote monitoring provides robust surveillance of patient and device status, preserving necessary patient contact while reducing the high volume of low-value resource utilization associated with guideline-based care. In the alert-driven pathway, patients’ CIEDs transmit only key findings via automated alerts or if patients have symptoms and initiate transmissions on their own; routine transmissions and most in-office interrogations are not performed.
Inclusion Criteria
Inclusion Criteria
Participants are eligible to be included in the study only if they satisfy all of the following criteria:
- 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 implantsin 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
Exclusion Criteria
Exclusion Criteria
Participants are excluded from the study if any of the following criteria apply
- Presence of insertable cardiac monitor, either in isolation or in combination with any 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.
