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

Bradycardia Clinical Trial

Official title:

Remote Implant Support

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01809652
• Other study ID #: Remote Implant Support
• Status: Completed
• Phase: N/A
• First received: March 11, 2013
• Last updated: April 23, 2014
• Start date: December 2013
• Est. completion date: April 2014

Study information

• Verified date: April 2014
• Source: Medtronic Cardiac Rhythm Disease Management
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 37
• Est. completion date: April 2014
• Est. primary completion date: April 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Bradycardia
• Death, Sudden, Cardiac
• Heart Arrest
• Sudden Cardiac Arrest

Intervention

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

Locations

Country	Name	City	State
United States	Centennial Heart	Nashville	Tennessee

Sponsors (1)

Lead Sponsor	Collaborator
Medtronic Cardiac Rhythm Disease Management

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	System Integrity	Percentage of patients whose implantable devices with clinically equivalent programming by remote support and local support.	At implant	No
Primary	Successful 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.	At implant	No