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

Not Applicable

Completed

• Conditions: Sudden Cardiac Arrest; Bradycardia
• Interventions: Other: Remote Implant Support Capability

• Registration Number: NCT01809652
• Lead Sponsor: Medtronic Cardiac Rhythm and Heart Failure

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2013-03-11
• Study First Submitted QC: 2013-03-12
• Study First Posted: 2013-03-13
• Study Start: 2013-12
• Status Verified: 2014-04
• Primary Completion: 2014-04
• Study Completion: 2014-04
• Last Update Submitted: 2014-04-23
• Last Update Posted: 2014-04-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 37

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Remote Implant Support	Remote Implant Support Capability	Implant supported through remote implant support capability

Primary Outcome Measures

Name	Time	Method
Successful Support	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.
System Integrity	At implant	Percentage of patients whose implantable devices with clinically equivalent programming by remote support and local support.

Trial Locations

Locations (1)

Centennial Heart; 🇺🇸 Nashville, Tennessee, United States