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

Remote Implant Support

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01809652

Enrollment

Registered

2013-03-13

Start date

2013-12-31

Completion date

2014-04-30

Last updated

2014-04-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bradycardia, Sudden Cardiac Arrest

Keywords

Pacemaker, Defibrillator, Remote Consultation

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.

Interventions

OTHERRemote 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

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

SUPPORTIVE_CARE

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
System Integrity	At implant	Percentage of patients whose implantable devices with clinically equivalent programming by remote support and local support.
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.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026