Remote Interrogation in Rural Emergency Departments

Remote Interrogation of Implantable Cardiac Devices in Rural Emergency Departments

Status

Withdrawn

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02421549

Acronym

REM RED

Enrollment

Registered

2015-04-20

Start date

2014-12-31

Completion date

2016-01-31

Last updated

2019-02-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Arrhythmias, Cardiac, Cardiovascular Disease, Heart Disease, Heart Failure

Keywords

Remote Monitoring, Remote Care, Cardiac Resynchronization Therapy, Pacemaker, Implantable Cardioverter Defibrillator

Brief summary

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.

Interventions

DEVICEUnpaired remote monitoring transmitter

Study design

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

DIAGNOSTIC

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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.

Design outcomes

Primary

Measure	Time frame	Description
Time to Clinical Specialist Treatment Decision	1 day	ED check in time to time of clinical specialist treatment decision.

Secondary

Measure	Time frame	Description
Health Care Utilization Rate	Within 30 days of initial ED visit	Device related hospitalizations, ED visits and unscheduled office visits/urgent care visits within 30 days of the initial ED visit.

Other

Measure	Time frame	Description
Time to Device Interrogation	1 day	ED check in time until time of device interrogation

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026