Ignite Creation Date:
2024-05-11 @ 8:31 AM
Last Modification Date:
2024-10-26 @ 3:29 PM
Study NCT ID:
NCT06404021
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-05-13
First Post:
2024-04-26
Brief Title:
Electronic Device Implantation Through Remote Guidance
Sponsor:
University of Calabria
Organization:
University of Calabria
Study Overview
Official Title:
Randomized Open-label Single-center Trial on Remote Assistance Implementing Certified Specialized Engineers During Interventional Cardiology Procedures
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Implantable cardioverter defibrillators ICD and cardiac resynchronization therapy defibrillator CRT-D implants are limited by availability and costs of field clinical specialist FCS bioengineers This study explores feasibility of remotely supported implantations through an internet based platform aiming at enhancing efficiency and overcoming geographical or pandemic related barriers The first phase of the study included programming and phantom assessments in 20 cases followed by 10 remote guided CRT-D and ICD implantations in additional heart failure patients compared to 20 procedures with FCS on site Data analysis revealed no significant differences in acute outcomes or electronic parameters at one year follow-up compared to on-site FCS Finally this study demonstrates the safety after testing at one year of follow-up
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None