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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Medtronic Cardiac Rhythm Disease Management
ClinicalTrials.gov Identifier:
NCT01809652
First received: March 11, 2013
Last updated: April 23, 2014
Last verified: April 2014
  Purpose

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 Intervention
Bradycardia
Sudden Cardiac Arrest
Other: Remote Implant Support Capability

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: Remote Implant Support

Resource links provided by NLM:


Further study details as provided by Medtronic Cardiac Rhythm Disease Management:

Primary Outcome Measures:
  • System Integrity [ Time Frame: At implant ] [ Designated as safety issue: No ]
    Percentage of patients whose implantable devices with clinically equivalent programming by remote support and local support.

  • Successful Support [ Time Frame: At implant ] [ Designated as safety issue: No ]
    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.


Enrollment: 37
Study Start Date: December 2013
Study Completion Date: April 2014
Primary Completion Date: April 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01809652

Locations
United States, Tennessee
Centennial Heart
Nashville, Tennessee, United States, 37203
Sponsors and Collaborators
Medtronic Cardiac Rhythm Disease Management
  More Information

No publications provided

Responsible Party: Medtronic Cardiac Rhythm Disease Management
ClinicalTrials.gov Identifier: NCT01809652     History of Changes
Other Study ID Numbers: Remote Implant Support
Study First Received: March 11, 2013
Last Updated: April 23, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Medtronic Cardiac Rhythm Disease Management:
Pacemaker
Defibrillator
Remote Consultation

Additional relevant MeSH terms:
Heart Arrest
Bradycardia
Death, Sudden, Cardiac
Heart Diseases
Cardiovascular Diseases
Arrhythmias, Cardiac
Pathologic Processes
Death, Sudden
Death

ClinicalTrials.gov processed this record on July 23, 2014