Ignite Creation Date:
2024-10-26 @ 3:37 PM
Last Modification Date:
2024-10-26 @ 3:37 PM
Study NCT ID:
NCT06539416
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-07-25
Brief Title:
Mixed Reality in MitraClip Implantation Preliminary Case Series
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Leveraging Mixed Reality in MitraClip Implantation A Preliminary Case Series Toward a Pilot Study
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
MIMIC
Brief Summary:
The study aims to evaluate the impact of mixed reality MR technology particularly using Hololens 20 and specialized software for three-dimensional DICOM image visualization on MitraClip implantation procedures This preliminary case series includes a comparative analysis of four MitraClip implantations assessing procedural efficiency radiation exposure and operator stress through both physiological and subjective measures
Detailed Description:
The advent of mixed reality MR technology especially when integrated with Hololens 20 and specialized software for three-dimensional DICOM image visualization offers promising avenues for enhancing precision and spatial awareness in interventional cardiology procedures This case series aims to preliminarily evaluate the impact of MR on MitraClip implantation processes setting the foundation for a comprehensive pilot study
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None