Remote Alert Pathway To Optimize CaRe of Cardiac Implantable Electrical Devices

Beth Israel Deaconess Medical Center120 enrolled

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

120

Conditions

Pacemaker DDD Implantable Defibrillator User

Interventions

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

Enrollment

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

Time frame: 6 months

Adherence

Proportion of cross-over

Time frame: 6 months

Secondary Outcomes

Major adverse cardiac events

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

Time frame: 6 months

Major adverse cardiac events

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

Time frame: 6 months

Effectiveness

Total number and type of device related encounters

Time frame: 6 months

Effectiveness

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

Time frame: 6 months

Connectivity

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

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: Baseline, 3 months, and 6 months

Remote Alert Pathway To Optimize CaRe of Cardiac Implantable Electrical Devices

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes

Central Contacts