Implantable Defibrillator User, Pacemaker DDD
Conditions
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.
Interventions
DEVICEAlert-based care
Alert-based care is an alternative strategy for longitudinal management of patients with wireless pacemakers and implantable defibrillators
DEVICEGuideline-based care
Guideline-based care is the current typical standard for longitudinal management of patients with wireless pacemakers and implantable defibrillators
Sponsors
Patient-Centered Outcomes Research Institute
Beth Israel Deaconess Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Enrollment | 6 months | Number of patients enrolled and randomized per site and per month, and cumulatively |
| Adherence | 6 months | Proportion of cross-over |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Major adverse cardiac events | 6 months | Incidence of MACE (i.e., death, stroke or systemic embolism, and unplanned cardiac device procedure) |
| Effectiveness | 6 months | Total number and type of device related encounters |
| Connectivity | 6 months | • Proportion of 24-, 48-, and 72-hour periods with versus without connected wireless monitoring |
| Quality of Life and Health Status | 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 |
Countries
United States
Contacts
Primary ContactLinda Valsdottir, MS
Outcome results
None listed