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NCT Number: NCT07352657

Remote Alert Pathway To Optimize CaRe of Cardiac Implantable Electrical Devices: The RAPTOR-CIED Study (Main Phase)

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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Key information

Conditions

Pacemaker Implantable Defibrillator

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Adult aged > 18 years
  • Clinically stable by investigator assessment
  • 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)
  • 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
  • Currently enrolled in remote monitoring as part of standard of care
  • Primary clinical electrophysiology follow-up at the enrolling center
  • Understands spoken and written English, Spanish, or Portuguese
  • Has sufficient cognitive function to answer standardized questions about study rationale and procedures.

Exclusion criteria

  • Presence of insertable cardiac monitor, either in isolation or in combination with any other CIED
  • Listed for cardiac transplantation prior to enrollment (N.B. if a patient becomes listed for transplantation during the study, they may continue study participation)
  • Participation in another study related to novel CIED technology or remote monitoring.

Treatment and study plan

Alert-based care

Other

Alert-based care is an alternative strategy for longitudinal management of patients with wireless pacemakers and implantable defibrillators

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

Primary outcomes

  1. Major adverse cardiac events

    Time frame: 2 years

    Incidence of MACE (i.e., death, stroke or systemic embolism, and unplanned cardiac device procedure)

  2. Effectiveness

    Time frame: 2 Years

    Proportion of total device related encounters that are actionable (e.g., changes in programming or treatment)

Study contacts

Contact information is provided by the study sponsor or research team.

Daniel B Kramer, MD, MPH

CONTACT

[email protected]

617-667-8800

Sponsors and collaborators

Lead sponsor

Beth Israel Deaconess Medical Center

Other

Collaborators

  • Patient-Centered Outcomes Research Institute

Registry information

Acronym: RAPTOR - MAIN

Important dates

Study start
2026
Primary completion
2030
Study completion
2031
First posted
Jan 20, 2026
Registry last updated
Feb 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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