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NCT Number: NCT06937658

Remote Alert Pathway To Optimize CaRe of Cardiac Implantable Electrical Devices

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.

Recruiting

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Key information

Conditions

Pacemaker Ddd Implantable Defibrillator User

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

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

Primary outcomes

  1. Enrollment

    Time frame: 6 months

    Number of patients enrolled and randomized per site and per month, and cumulatively

  2. Adherence

    Time frame: 6 months

    Proportion of cross-over

Secondary outcomes

  1. Major adverse cardiac events

    Time frame: 6 months

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

  2. Major adverse cardiac events

    Time frame: 6 months

    Incidence of arrhythmia events, individual components of MACE, and health services use (i.e., hospital presentations)

  3. Effectiveness

    Time frame: 6 months

    Total number and type of device related encounters

  4. Effectiveness

    Time frame: 6 months

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

  5. Connectivity

    Time frame: 6 months

    • Proportion of 24-, 48-, and 72-hour periods with versus without connected wireless monitoring

  6. Quality of Life and Health Status

    Time frame: Baseline, 3 months, and 6 months

    EuroQol 5-dimensional questionnaire, five-level version (EQ-5D-5L) - 5 questions are scored from 1 to 5, with higher scores indicating worse outcomes

  7. Quality of Life and Health Status

    Time frame: Baseline, 3 months, and 6 months

    Cardiac Anxiety Questionnaire (CAQ) - scored from 0 to 72, with a higher score corresponding to higher cardiac anxiety

  8. Quality of Life and Health Status

    Time frame: Baseline, 3 months, and 6 months

    Patient Health Questionnaire depression scale (PHQ-8) - scored from 0 to 24, with a higher score indicating worse symptoms

  9. Quality of Life and Health Status

    Time frame: Baseline, 3 months, and 6 months

    Patient Activation Measure (PAM) - scored from 0 to 100, with a higher score indicating better outcomes

Study contacts

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

Linda Valsdottir, MS

CONTACT

[email protected]

6176678800

Sponsors and collaborators

Lead sponsor

Beth Israel Deaconess Medical Center

Other

Collaborators

  • Patient-Centered Outcomes Research Institute

Registry information

Acronym: RAPTOR-CIED

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Apr 22, 2025
Registry last updated
Jan 7, 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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