Remote Device Interrogation In The Emergency Department

Abbott Medical Devices99 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

DIAGNOSTIC

Masking

NONE

Enrollment

Conditions

Heart Disease Cardiovascular Disease Heart Failure Arrhythmias, Cardiac

Interventions

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Time to Interrogation

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.

Time frame: On day of Emergency Department admission

Secondary Outcomes

Time to Clinical/Treatment Decision

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).