Study Results
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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WITHDRAWN
PHASE4
INTERVENTIONAL
2014-12-31
2016-01-31
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
DIAGNOSTIC
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.
Unpaired remote monitoring transmitter
Interrogation with Programmer
Interrogation with programmer Interrogation with programmer according to usual standard of care
No interventions assigned to this group
Interventions
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Unpaired remote monitoring transmitter
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
18 Years
ALL
No
Sponsors
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Abbott Medical Devices
INDUSTRY
Responsible Party
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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
Countries
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Other Identifiers
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60054491
Identifier Type: -
Identifier Source: org_study_id
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