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.

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Key information

Conditions

Bradycardia Arrhythmias, Cardiac Cardiovascular Diseases Death Death, Sudden Death, Sudden, Cardiac Heart Arrest Heart Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Sudden Cardiac Arrest

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Centennial Heart

Nashville, Tennessee, 37203, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Remote Implant Support Capability

Other

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

Primary outcomes

System Integrity

Time frame: At implant

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

Time frame: At implant

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.

Sponsors and collaborators

Lead sponsor

Medtronic Cardiac Rhythm and Heart Failure

Industry

Registry information

Official study title

Remote Implant Support

Important dates

Study start: 2013
Primary completion: 2014
Study completion: 2014
First posted: Mar 13, 2013
Registry last updated: Apr 24, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed