NCT01809652

Feasibility Study of Remote Support for Implantable Pulse Generator (IPG)/Implantable Cardioverter Defibrillator (ICD) Implant

Remote Implant Support

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 37 (actual)
• Sponsor: Medtronic Cardiac Rhythm and Heart Failure · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

• Bradycardia
• Sudden Cardiac Arrest

Interventions

Type	Name	Description
OTHER	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

Timeline

• Start date: 2013-12-01
• Primary completion: 2014-04-01
• Completion: 2014-04-01
• First posted: 2013-03-13
• Last updated: 2014-04-24

Locations

1 site across 1 country: United States