Remote Interrogation in Rural Emergency Departments (REM RED)

Abbott

Status and phase: Withdrawn; Phase 4

Conditions: Arrhythmias, Cardiac; Heart Failure; Heart Disease; Cardiovascular Disease

Treatments: Device: Unpaired remote monitoring transmitter

Study type: Interventional

Funder types: Industry

Identifiers

NCT02421549

60054491

Details and patient eligibility

About

A retrospective, multi-center, proof-of-concept study to evaluate the use of remote monitoring in rural emergency departments to decrease time to treatment decision for pacemaker and defibrillator patients using the St Jude Medical Merlin@home transmitter. The purpose of the study is to determine if utilization of remote monitoring technology in a rural emergency department may improve patient care.

Up to 10 rural ED sites will enroll a total of 200 patients. One hundred patients will be in the remote monitoring group comprised of patients with SJM devices compatible with the unpaired transmitter and 100 patients will be in the usual medical care group comprised of patients with SJM devices that are not compatible with the unpaired transmitter or that have a competitor's device.

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Presents to Emergency Department with an implanted pacemaker or defibrillator.
2. Are 18 years of age or older.
3. Are willing and able to provide informed consent for study participation.
4. Are willing and able to complete a 30-60 day follow up phone call.

Exclusion criteria

1. Are unwilling to provide written informed consent.

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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0 participants in 2 patient groups

Interrogation with unpaired remote monitoring transmitter

Active Comparator group

Description:

Interrogation with unpaired remote monitoring transmitter Interrogation with an unpaired remote monitoring transmitter for devices that are compatible.

Treatment:

Device: Unpaired remote monitoring transmitter

Interrogation with Programmer

No Intervention group

Description:

Interrogation with programmer Interrogation with programmer according to usual standard of care