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| Name | Class |
|---|---|
| Patient-Centered Outcomes Research Institute | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Guideline-based Care | Active Comparator | 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 |
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| Alert-based Care | Active Comparator | Remote monitoring programming scheduled for alert transmissions and patient-initiated transmissions only |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Alert-based care | Device | Alert-based care is an alternative strategy for longitudinal management of patients with wireless pacemakers and implantable defibrillators |
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| Measure | Description | Time Frame |
|---|---|---|
| Enrollment | Number of patients enrolled and randomized per site and per month, and cumulatively | 6 months |
| Adherence | Proportion of cross-over | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Major adverse cardiac events | Incidence of MACE (i.e., death, stroke or systemic embolism, and unplanned cardiac device procedure) | 6 months |
| Major adverse cardiac events | Incidence of arrhythmia events, individual components of MACE, and health services use (i.e., hospital presentations) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Linda Valsdottir, MS | Contact | 6176678800 | lvalsdot@bidmc.harvard.edu |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beth Israel Deaconess Medical Center | Recruiting | Boston | Massachusetts | 02215 | United States |
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| Guideline-based care | Device | Guideline-based care is the current typical standard for longitudinal management of patients with wireless pacemakers and implantable defibrillators |
|
| 6 months |
| Effectiveness | Total number and type of device related encounters | 6 months |
| Effectiveness | Proportion of total device related encounters that are actionable (e.g., changes in programming or treatment) | 6 months |
| Connectivity | • Proportion of 24-, 48-, and 72-hour periods with versus without connected wireless monitoring | 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 | 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 | 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 | 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 | Baseline, 3 months, and 6 months |