Remote Alert Pathway To Optimize CaRe of Cardiac Implantable Electrical Devices: The RAPTOR-CIED Study (Main Phase)
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Enrollment
- 3,000
- Locations
- 1
- Primary Endpoint
- Major adverse cardiac events
Study Overview
Brief Summary
he 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 Main Phase of the study.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion 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 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.
Exclusion Criteria
- •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.
Arms & Interventions
Guideline-based Care
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
Intervention: Guideline-based Care (Other)
Alert-based care
Alert-based care is an alternative strategy for longitudinal management of patients with wireless pacemakers and implantable defibrillators
Intervention: Alert-based care (Other)
Outcomes
Primary Outcomes
Major adverse cardiac events
Time Frame: 2 years
Incidence of MACE (i.e., death, stroke or systemic embolism, and unplanned cardiac device procedure)
Effectiveness
Time Frame: 2 Years
Proportion of total device related encounters that are actionable (e.g., changes in programming or treatment)
Secondary Outcomes
No secondary outcomes reported
Investigators
Daniel B. Kramer
Associate Professor of Medicine
Beth Israel Deaconess Medical Center