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| Name | Class |
|---|---|
| Patient-Centered Outcomes Research Institute | OTHER |
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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.
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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 | Alert-based care is an alternative strategy for longitudinal management of patients with wireless pacemakers and implantable defibrillators |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Alert-based care | Other | 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 |
|---|---|---|
| Major adverse cardiac events | Incidence of MACE (i.e., death, stroke or systemic embolism, and unplanned cardiac device procedure) | 2 years |
| Effectiveness | Proportion of total device related encounters that are actionable (e.g., changes in programming or treatment) | 2 Years |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Daniel B Kramer, MD, MPH | Contact | 617-667-8800 | dkramer@bidmc.harvard.edu |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beth Israel Deaconess Medical Center | Boston | Massachusetts | 02215 | United States |
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| Guideline-based Care | Other | 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 |
|