Feasibility Study of Remote Support for Implantable Pulse Generator (IPG)/Implantable Cardioverter Defibrillator (ICD) Implant
Remote Implant Support
1 other identifier
interventional
37
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Dec 2013
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 11, 2013
CompletedFirst Posted
Study publicly available on registry
March 13, 2013
CompletedStudy Start
First participant enrolled
December 1, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2014
CompletedApril 24, 2014
April 1, 2014
4 months
March 11, 2013
April 23, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
System Integrity
Percentage of patients whose implantable devices with clinically equivalent programming by remote support and local support.
At implant
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
Study Arms (1)
Remote Implant Support
EXPERIMENTALImplant supported through remote implant support capability
Interventions
Use of audio and video telepresence and remote control of device programmer to allow implant to be supported from a remote location
Eligibility Criteria
You may qualify if:
- Planned IPG implant or planned ICD (without CRT) implant
- Signed informed consent
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Centennial Heart
Nashville, Tennessee, 37203, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 11, 2013
First Posted
March 13, 2013
Study Start
December 1, 2013
Primary Completion
April 1, 2014
Study Completion
April 1, 2014
Last Updated
April 24, 2014
Record last verified: 2014-04