Remote Device Interrogation In The Emergency Department

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

99 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-09-30

Study Completion Date

2015-07-31

Brief Summary

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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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Detailed Description

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Conditions

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Heart Disease Cardiovascular Disease Heart Failure Arrhythmias, Cardiac

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Interrogation with unpaired remote transmitter

Interrogation with an unpaired remote monitoring transmitter for devices that are compatible.

Group Type ACTIVE_COMPARATOR

Unpaired remote monitoring transmitter

Intervention Type DEVICE

Unpaired remote monitoring transmitter

Interrogation with programmer

Interrogation with programmer according to usual standard of care

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Unpaired remote monitoring transmitter

Intervention Type DEVICE

Other Intervention Names

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St. Jude Medical Merlin@home remote monitoring transmitter

Eligibility Criteria

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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.