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OpenTrials
Completed

NCT Number: NCT01871090

Remote Device Interrogation In The Emergency Department

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.

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Key information

Conditions

Heart Disease Arrhythmias, Cardiac Cardiovascular Disease Cardiovascular Diseases Heart Diseases Heart Failure Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Genesis Healthcare System

Zanesville, Ohio, 43701, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • None

Treatment and study plan

Unpaired remote monitoring transmitter

Device

Unpaired remote monitoring transmitter

Other names: St. Jude Medical Merlin@home remote monitoring transmitter

Primary outcomes

  1. Time to Interrogation

    Time frame: 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 outcomes

  1. Time to Clinical/Treatment Decision

    Time frame: 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).

Other outcomes

  1. Length of Emergency Department Stay

    Time frame: On day of Emergency Department admission

    Defined as the time from the Emergency Department Check In Time until the Emergency Department Check Out Time (discharged/leaves Emergency Department or admitted to hospital).

Sponsors and collaborators

Lead sponsor

Abbott Medical Devices

Industry

Registry information

Acronym: REMEDY

Important dates

Study start
2013
Primary completion
2015
Study completion
2015
First posted
Jun 6, 2013
Registry last updated
Feb 15, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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