Clinical trial NCT06937658: Remote Alert Pathway To Optimize CaRe of Cardiac Implantable Electrical Devices
Official title: Remote Alert Pathway To Optimize CaRe of Cardiac Implantable Electrical Devices
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Pacemaker DDD
Implantable Defibrillator User
Lead sponsor: Beth Israel Deaconess Medical Center
Sponsor class: OTHER
Collaborators: name: Patient-Centered Outcomes Research Institute
First posted: 2025-04-22
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Enrollment
timeFrame: 6 months
measure: Adherence
timeFrame: 6 months
Secondary outcomes:
measure: Major adverse cardiac events
timeFrame: 6 months
measure: Major adverse cardiac events
timeFrame: 6 months
measure: Effectiveness
timeFrame: 6 months
measure: Effectiveness
timeFrame: 6 months
measure: Connectivity
timeFrame: 6 months
measure: Quality of Life and Health Status
timeFrame: Baseline, 3 months, and 6 months
measure: Quality of Life and Health Status
timeFrame: Baseline, 3 months, and 6 months
measure: Quality of Life and Health Status
timeFrame: Baseline, 3 months, and 6 months
measure: Quality of Life and Health Status
timeFrame: Baseline, 3 months, and 6 months
Other outcomes:
Locations:
city: Boston
country: United States
facility: Beth Israel Deaconess Medical Center
state: Massachusetts
Study officials:
References: