Remote Alert Pathway To Optimize CaRe of Cardiac Implantable Electrical Devices

Part of paid clinical trials in Boston, Massachusetts.

Sponsor
Beth Israel Deaconess Medical Center
Study ID
NCT06937658
Status
Recruiting
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Conditions

  • Implantable Defibrillator User
  • Pacemaker DDD

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Alert-based care — DEVICE
    Alert-based care is an alternative strategy for longitudinal management of patients with wireless pacemakers and implantable defibrillators
  • Guideline-based care — DEVICE
    Guideline-based care is the current typical standard for longitudinal management of patients with wireless pacemakers and implantable defibrillators

Study Details

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.

Key Dates

Start date
May 1, 2025
Status verified
Jan 2026
Primary completion
Jun 30, 2026
Completion
Jun 30, 2026

Study Design

Enrollment
120 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: 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
  • Active Comparator: Alert-based Care
    Remote monitoring programming scheduled for alert transmissions and patient-initiated transmissions only

Primary Outcome Measure

Enrollment [ Time Frame: 6 months ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Beth Israel Deaconess Medical CenterBostonMassachusetts02215
Daniel B Kramer, MD
[email protected]
617-667-8800
Linda Valsdottir, MS
[email protected]
617-632-7652
Daniel B Kramer, MD (PRINCIPAL_INVESTIGATOR)

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