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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01809652
Recruitment Status : Completed
First Posted : March 13, 2013
Last Update Posted : April 24, 2014
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Bradycardia Sudden Cardiac Arrest Other: Remote Implant Support Capability Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 37 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Remote Implant Support
Study Start Date : December 2013
Actual Primary Completion Date : April 2014
Actual Study Completion Date : April 2014

Arm Intervention/treatment
Experimental: Remote Implant Support
Implant supported through remote implant support capability
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

Primary Outcome Measures :
  1. System Integrity [ Time Frame: At implant ]
    Percentage of patients whose implantable devices with clinically equivalent programming by remote support and local support.

  2. 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.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01809652

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United States, Tennessee
Centennial Heart
Nashville, Tennessee, United States, 37203
Sponsors and Collaborators
Medtronic Cardiac Rhythm and Heart Failure

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Responsible Party: Medtronic Cardiac Rhythm and Heart Failure Identifier: NCT01809652     History of Changes
Other Study ID Numbers: Remote Implant Support
First Posted: March 13, 2013    Key Record Dates
Last Update Posted: April 24, 2014
Last Verified: April 2014
Keywords provided by Medtronic Cardiac Rhythm and Heart Failure:
Remote Consultation
Additional relevant MeSH terms:
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Death, Sudden, Cardiac
Heart Arrest
Heart Diseases
Cardiovascular Diseases
Arrhythmias, Cardiac
Pathologic Processes
Death, Sudden