An interventional study of Alert-based care and Guideline-based care in Pacemaker DDD and Implantable Defibrillator User, sponsored by Beth Israel Deaconess Medical Center. Recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-01-07.
Sponsored by Beth Israel Deaconess Medical Center · Not applicable, Interventional, and Treatment
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.
Beth Israel Deaconess Medical Center is the lead sponsor of 560 studies on the registry; 80 are open to participants now.
Of its 75 completed or terminated interventional studies of FDA-regulated products, 61 (81%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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
Remote monitoring programming scheduled for alert transmissions and patient-initiated transmissions only
Device: Alert-based care
Alert-based care is an alternative strategy for longitudinal management of patients with wireless pacemakers and implantable defibrillators
Guideline-based care is the current typical standard for longitudinal management of patients with wireless pacemakers and implantable defibrillators
Enrollment
Number of patients enrolled and randomized per site and per month, and cumulatively
Time frame: 6 months
Adherence
Proportion of cross-over
Time frame: 6 months
Major adverse cardiac events
Incidence of MACE (i.e., death, stroke or systemic embolism, and unplanned cardiac device procedure)
Time frame: 6 months
Major adverse cardiac events
Incidence of arrhythmia events, individual components of MACE, and health services use (i.e., hospital presentations)
Time frame: 6 months
Effectiveness
Total number and type of device related encounters
Time frame: 6 months
Effectiveness
Proportion of total device related encounters that are actionable (e.g., changes in programming or treatment)
Time frame: 6 months
Connectivity
• Proportion of 24-, 48-, and 72-hour periods with versus without connected wireless monitoring
Time frame: 6 months
Quality of Life and Health Status
EuroQol 5-dimensional questionnaire, five-level version (EQ-5D-5L) - 5 questions are scored from 1 to 5, with higher scores indicating worse outcomes
Time frame: Baseline, 3 months, and 6 months
Quality of Life and Health Status
Cardiac Anxiety Questionnaire (CAQ) - scored from 0 to 72, with a higher score corresponding to higher cardiac anxiety
Time frame: Baseline, 3 months, and 6 months
Quality of Life and Health Status
Patient Health Questionnaire depression scale (PHQ-8) - scored from 0 to 24, with a higher score indicating worse symptoms
Time frame: Baseline, 3 months, and 6 months
Quality of Life and Health Status
Patient Activation Measure (PAM) - scored from 0 to 100, with a higher score indicating better outcomes
Time frame: Baseline, 3 months, and 6 months
Plan to share: Undecided
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Beth Israel Deaconess Medical Center