Remote Interrogation in Rural Emergency Departments

Phase 4

Withdrawn

• Conditions: Heart Disease; Cardiovascular Disease; Heart Failure; Arrhythmias, Cardiac
• Interventions: Device: Unpaired remote monitoring transmitter

• Registration Number: NCT02421549
• Lead Sponsor: Abbott Medical Devices

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-12
• Study First Submitted: 2015-04-13
• Study First Submitted QC: 2015-04-15
• Study First Posted: 2015-04-20
• Primary Completion: 2016-01
• Study Completion: 2016-01
• Status Verified: 2019-01
• Last Update Submitted: 2019-01-31
• Last Update Posted: 2019-02-04

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Interrogation with unpaired remote monitoring transmitter	Unpaired remote monitoring transmitter	Interrogation with unpaired remote monitoring transmitter Interrogation with an unpaired remote monitoring transmitter for devices that are compatible.

Primary Outcome Measures

Name	Time	Method
Time to Clinical Specialist Treatment Decision	1 day	ED check in time to time of clinical specialist treatment decision.

Secondary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

New Mexico Heart Institute; 🇺🇸 Albuquerque, New Mexico, United States