Health TrialsbyHealthPanel

Remote Alert Pathway To Optimize CaRe of Cardiac Implantable Electrical Devices

ConditionsPacemaker DDDImplantable Defibrillator User
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorBeth Israel Deaconess Medical Center

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Alert-based care

    Device

    Alert-based care is an alternative strategy for longitudinal management of patients with wireless pacemakers and implantable defibrillators

  • Guideline-based care

    Device

    Guideline-based care is the current typical standard for longitudinal management of patients with wireless pacemakers and implantable defibrillators

Treatment groups

120 Participants
are divided into 2 treatment groups
Group A: Guideline-based CareActive comparator 1 intervention
Group B: Alert-based CareActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Enrollment

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

Time frame
6 months
2

Adherence

Proportion of cross-over

Time frame
6 months

Secondary outcomes

1

Major adverse cardiac events

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

Time frame
6 months
2

Major adverse cardiac events

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

Time frame
6 months
3

Effectiveness

Total number and type of device related encounters

Time frame
6 months
4

Effectiveness

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

Time frame
6 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Beth Israel Deaconess Medical Center

Lead sponsor

Patient-Centered Outcomes Research Institute

Collaborator

Source ClinicalTrials.gov
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