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NCT01809652 · ClinicalTrials.gov registry record · NA
Feasibility Study of Remote Support for Implantable Pulse Generator (IPG)/Implantable Cardioverter Defibrillator (ICD) Implant
A NA study of Bradycardia and Sudden Cardiac Arrest, sponsored by Medtronic Cardiac Rhythm and Heart Failure.
- Completed
- Registry status
- NA
- Development phase
- 37
- Enrollment target
- 1
- Study location
NCT01809652 is a NA study of Bradycardia and Sudden Cardiac Arrest that has completed, run by Medtronic Cardiac Rhythm and Heart Failure. The registered enrollment target is 37 participants, below the 4,411-participant average among 29 other Bradycardia trials with a reported enrollment target (99% lower). The trial reports 1 study location across 1 state.
The verdict
NCT01809652, a NA study of Bradycardia and Sudden Cardiac Arrest, has completed, sponsored by Medtronic Cardiac Rhythm and Heart Failure.
- COMPLETED
- Registry status
- NA
- Development phase
- 37 participants
- Enrollment target
- 1
- Study location
Study Summary
The purpose of this study is to gain real world, live implant experience with the remote implant support system. This system is intended to provide the technical support for device implants from a remote location through telepresence (audio and video) and remote control. Specifically, the goals of this study are to corroborate bench testing, assess the performance of the system, gain understanding of the workflows, customer experience, and logistics. 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.
Conditions Studied
Interventions
- OTHER Remote Implant Support Capability
Study Locations (1)
Tennessee
- Centennial Heart - Nashville
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 37 participants |
| Start Date | 2013-12 |
| Est. Completion | 2014-04 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01809652
The ClinicalTrials.gov registry entry for NCT01809652 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 37 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 4,411-participant average among 29 other Bradycardia trials with a reported enrollment target (99% lower). The listed sponsor is Medtronic Cardiac Rhythm and Heart Failure, which has 115 total studies on file at ClinicalTrials.gov.
The record links to 2 conditions, with Bradycardia appearing as the primary indexed condition, and to 1 intervention - of which Remote Implant Support Capability is the first listed.
NCT01809652 reports 1 study location spanning 1 distinct geographic area - top geographies include Tennessee.
Frequently Asked Questions
What is clinical trial NCT01809652 about?
NCT01809652 is a clinical study titled "Feasibility Study of Remote Support for Implantable Pulse Generator (IPG)/Implantable Cardioverter Defibrillator (ICD) Implant". The purpose of this study is to gain real world, live implant experience with the remote implant support system. This system is intended to provide the technical support for device implants from a remote location through telepresence (audio and video) and remote control. Specifically, the goals of t...
What is the current status of trial NCT01809652?
This trial is currently completed. It is a NA study. The enrollment target is 37 participants. The study started on 2013-12. Estimated completion is 2014-04.
What conditions does trial NCT01809652 study?
This clinical trial studies the following conditions: Bradycardia, Sudden Cardiac Arrest.
What interventions are being tested in trial NCT01809652?
The interventions under investigation include: Remote Implant Support Capability (OTHER).
Who is sponsoring clinical trial NCT01809652?
This trial is sponsored by Medtronic Cardiac Rhythm and Heart Failure, which has 115 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01809652 being conducted?
This trial has 1 study location across Tennessee. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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