Remote Alert Pathway To Optimize CaRe of Cardiac Implantable Electrical Devices (RAPTOR-CIED)

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.

Study Overview

• Status: Recruiting
• Conditions: Pacemaker DDD; Implantable Defibrillator User
• Intervention / Treatment: Device: Guideline-based care; Device: Alert-based care

• Study Type: Interventional
• Enrollment (Estimated): 120
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Linda Valsdottir, MS; Phone Number: 6176678800; Email: lvalsdot@bidmc.harvard.edu

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02215
      • Recruiting
      • Beth Israel Deaconess Medical Center
      • Contact: Daniel B Kramer, MD; Phone Number: 617-667-8800; Email: dkramer@bidmc.harvard.edu
      • Contact: Linda Valsdottir, MS; Phone Number: 617-632-7652; Email: lvalsdot@bidmc.harvard.edu
      • Principal Investigator: Daniel B Kramer, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Adult aged > 18 years
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:

1. Presence of insertable cardiac monitor, either in isolation or in combination with any other CIED
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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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	Device: Guideline-based care; Guideline-based care is the current typical standard for longitudinal management of patients with wireless pacemakers and implantable defibrillators
Active Comparator: Alert-based Care; Remote monitoring programming scheduled for alert transmissions and patient-initiated transmissions only	Device: Alert-based care; Alert-based care is an alternative strategy for longitudinal management of patients with wireless pacemakers and implantable defibrillators

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Enrollment	Number of patients enrolled and randomized per site and per month, and cumulatively	6 months
Adherence	Proportion of cross-over	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Major adverse cardiac events	Incidence of MACE (i.e., death, stroke or systemic embolism, and unplanned cardiac device procedure)	6 months
Major adverse cardiac events	Incidence of arrhythmia events, individual components of MACE, and health services use (i.e., hospital presentations)	6 months
Effectiveness	Total number and type of device related encounters	6 months
Effectiveness	Proportion of total device related encounters that are actionable (e.g., changes in programming or treatment)	6 months
Connectivity	• Proportion of 24-, 48-, and 72-hour periods with versus without connected wireless monitoring	6 months
Quality of Life and Health Status	EuroQol 5-dimensional questionnaire, five-level version (EQ-5D-5L) - 5 questions are scored from 1 to 5, with higher scores indicating worse outcomes	Baseline, 3 months, and 6 months
Quality of Life and Health Status	Cardiac Anxiety Questionnaire (CAQ) - scored from 0 to 72, with a higher score corresponding to higher cardiac anxiety	Baseline, 3 months, and 6 months
Quality of Life and Health Status	Patient Health Questionnaire depression scale (PHQ-8) - scored from 0 to 24, with a higher score indicating worse symptoms	Baseline, 3 months, and 6 months
Quality of Life and Health Status	Patient Activation Measure (PAM) - scored from 0 to 100, with a higher score indicating better outcomes	Baseline, 3 months, and 6 months

Collaborators and Investigators

• Sponsor: Beth Israel Deaconess Medical Center
• Collaborators: Patient-Centered Outcomes Research Institute

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2025
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): June 30, 2026

Study Registration Dates

• First Submitted: April 8, 2025
• First Submitted That Met QC Criteria: April 18, 2025
• First Posted (Actual): April 22, 2025

Study Record Updates

• Last Update Posted (Actual): January 7, 2026
• Last Update Submitted That Met QC Criteria: January 5, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: PLACER-2023C3-34968

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes