Remote Device Interrogation In The Emergency Department

Not Applicable

Completed

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

• Registration Number: NCT01871090
• Lead Sponsor: Abbott Medical Devices

Brief Summary

A prospective, post market, non-randomized study to evaluate the reduction in time to interrogation for patients with St. Jude Medical remote care compatible devices interrogated by the unpaired Merlin@home transmitter in the Emergency Department (ED). Two sites will enroll up to 100 patients total.

Expected duration of the study is 6 months. Once enrolled the patient will participate in the study for the duration of the Emergency Department stay, until discharged or admitted to the hospital.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2013-06-04
• Study First Submitted QC: 2013-06-04
• Study First Posted: 2013-06-06
• Study Start: 2013-09
• Primary Completion: 2015-04
• Study Completion: 2015-07
• Results First Submitted: 2016-06-02
• Results First Submitted QC: 2016-11-01
• Results First Posted: 2016-12-28
• Status Verified: 2019-01
• Last Update Submitted: 2019-01-31
• Last Update Posted: 2019-02-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 99

Inclusion Criteria

1. Present to Emergency Department with an implanted pacemaker or defibrillator.
2. Are 18 years of age or older, or of legal age to give informed consent specific to state law.
3. Are willing and able to provide informed consent for study participation.

Exclusion Criteria

• None

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Time to Interrogation	On day of Emergency Department admission	Time to interrogation is defined as the time from Triage (decision to interrogate the device) until the first of: Completion of interrogation, Time of Clinical/Treatment decision, or Emergency Department check out time.

Secondary Outcome Measures

Name	Time	Method
Time to Clinical/Treatment Decision	On day of Emergency Department admission	Defined as the time from the Emergency Department Check In Time until the first of: Time of Clinical/Treatment Decision or Emergency Department Check Out Time (discharged/leaves Emergency Department or admitted to hospital).

Trial Locations

Locations (1)

Genesis Healthcare System; 🇺🇸 Zanesville, Ohio, United States