Remote Alert Pathway To Optimize CaRe of Cardiac Implantable Electrical Devices
NCT ID: NCT06937658
Last Updated: 2026-01-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
120 participants
INTERVENTIONAL
2025-05-01
2026-06-30
Brief Summary
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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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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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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
Guideline-based care
Guideline-based care is the current typical standard for longitudinal management of patients with wireless pacemakers and implantable defibrillators
Alert-based Care
Remote monitoring programming scheduled for alert transmissions and patient-initiated transmissions only
Alert-based care
Alert-based care is an alternative strategy for longitudinal management of patients with wireless pacemakers and implantable defibrillators
Interventions
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Alert-based care
Alert-based care is an alternative strategy for longitudinal management of patients with wireless pacemakers and implantable defibrillators
Guideline-based care
Guideline-based care is the current typical standard for longitudinal management of patients with wireless pacemakers and implantable defibrillators
Eligibility Criteria
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Inclusion Criteria
2. Clinically stable by investigator assessment
3. 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)
4. 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
5. Currently enrolled in remote monitoring as part of standard of care
6. Primary clinical electrophysiology follow-up at the enrolling center
7. Understands spoken and written English, Spanish, or Portuguese
8. Has sufficient cognitive function to answer standardized questions about study rationale and procedures.
Exclusion Criteria
2. Listed for cardiac transplantation prior to enrollment (N.B. if a patient becomes listed for transplantation during the study, they may continue study participation)
3. Participation in another study related to novel CIED technology or remote monitoring.
18 Years
ALL
No
Sponsors
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Beth Israel Deaconess Medical Center
OTHER
Patient-Centered Outcomes Research Institute
OTHER
Responsible Party
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Daniel B. Kramer
Associate Professor of Medicine
Locations
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Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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PLACER-2023C3-34968
Identifier Type: -
Identifier Source: org_study_id
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