Remote Alert Pathway To Optimize CaRe of Cardiac Implantable Electrical Devices
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Alert-based care, Guideline-based care.
- Who it may be relevant to
- Registry conditions: Pacemaker DDD, Implantable Defibrillator User. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
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.
Interventions
- Device Alert-based care
Alert-based care is an alternative strategy for longitudinal management of patients with wireless pacemakers and implantable defibrillators - Device Guideline-based care
Guideline-based care is the current typical standard for longitudinal management of patients with wireless pacemakers and implantable defibrillators
Primary outcome measures
- Enrollment [Time frame: 6 months]
- Adherence [Time frame: 6 months]
Secondary outcome measures (9)
- Major adverse cardiac events [Time frame: 6 months]
- Major adverse cardiac events [Time frame: 6 months]
- Effectiveness [Time frame: 6 months]
- Effectiveness [Time frame: 6 months]
- Connectivity [Time frame: 6 months]
- Quality of Life and Health Status [Time frame: Baseline, 3 months, and 6 months]
- Quality of Life and Health Status [Time frame: Baseline, 3 months, and 6 months]
- Quality of Life and Health Status [Time frame: Baseline, 3 months, and 6 months]
- Quality of Life and Health Status [Time frame: Baseline, 3 months, and 6 months]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
United States · 1 center
- Beth Israel Deaconess Medical Center — Boston
Identifiers
NCT: NCT06937658 · PLACER-2023C3-34968