Remote Interrogation in Rural Emergency Departments

NCT ID: NCT02421549

Last Updated: 2019-02-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE4

Study Classification

INTERVENTIONAL

Study Start Date

2014-12-31

Study Completion Date

2016-01-31

Brief Summary

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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

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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 monitoring transmitter

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

Group Type ACTIVE_COMPARATOR

Unpaired remote monitoring transmitter

Intervention Type DEVICE

Interrogation with Programmer

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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SJM Merlin@home remote monitoring transmitter

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Abbott Medical Devices

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Ross Downey, MD

Role: PRINCIPAL_INVESTIGATOR

New Mexico Heart Institute, PA

Locations

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New Mexico Heart Institute

Albuquerque, New Mexico, United States

Site Status

Countries

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United States

Other Identifiers

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60054491

Identifier Type: -

Identifier Source: org_study_id

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