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

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 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.

Use of audio and video telepresence and remote control of device programmer to allow implant to be supported from a remote location

Percentage of patients whose implantable devices with clinically equivalent programming by remote support and local support.

Percentage of implant attempts with successful support. If the local support person does not participate in any part of the surgery, other than observing, then the remote support will be called a success.

Inclusion Criteria: Planned IPG implant or planned ICD (without CRT) implant Signed informed consent Exclusion Criteria: Pacing dependency 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