Feasibility Study of Remote Support for Implantable Pulse Generator (IPG)/Implantable Cardioverter Defibrillator (ICD) Implant
NCT ID: NCT01809652
Last Updated: 2014-04-24
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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COMPLETED
NA
37 participants
INTERVENTIONAL
2013-12-31
2014-04-30
Brief Summary
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The intent of the remote support model is to provide the same support that would typically be provided by a local support person, only remotely. As such, the remote support person would only perform actions that a local support person would routinely do under the direction of a physician. This may involve observing patient data, providing technical support and advice, and performing testing and device reprogramming via remote control of the programmer.
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
SUPPORTIVE_CARE
NONE
Study Groups
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Remote Implant Support
Implant supported through remote implant support capability
Remote Implant Support Capability
Use of audio and video telepresence and remote control of device programmer to allow implant to be supported from a remote location
Interventions
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Remote Implant Support Capability
Use of audio and video telepresence and remote control of device programmer to allow implant to be supported from a remote location
Eligibility Criteria
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Inclusion Criteria
* Signed informed consent
Exclusion Criteria
* Defibrillation threshold testing planned
* Basal ventricular rate \>110 beats per minute
* Younger than 18 years
* Pregnant
* Currently involved in another IPG or ICD related clinical trial
18 Years
ALL
No
Sponsors
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Medtronic Cardiac Rhythm and Heart Failure
INDUSTRY
Responsible Party
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Locations
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Centennial Heart
Nashville, Tennessee, United States
Countries
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Other Identifiers
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Remote Implant Support
Identifier Type: -
Identifier Source: org_study_id
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