Ignite Creation Date:
2025-12-24 @ 11:56 PM
Ignite Modification Date:
2025-12-25 @ 9:52 PM
Study NCT ID:
NCT01821651
Status:
UNKNOWN
Last Update Posted:
2013-06-19
First Post:
2012-12-10
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Use of Standardized Diagnostic Imaging Data for Image Fusion in the Hybrid Operating Room
Sponsor:
University of Zurich
Organization:
Study Overview
Official Title:
Use of Standardized Diagnostic Imaging Data (Computertomography, Angiography, Echocardiography) for Image Fusion in the Hybrid Operating Room
Status:
UNKNOWN
Status Verified Date:
2013-06
Last Known Status:
RECRUITING
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:
Objectives:
Goal of the study is to investigate the potential benefit that transcatheter interventions such as Transcatheter Aortic Valve Implantation (TAVI), MitraClip, Left Atrial Appendage Closure and catheter Ablation can gain from multimodal image fusion techniques as they are available in the Hybrid suite.
Both the HeartNavigator and the EchoNav aim at decreasing the exposure to radiation and contrast agent, to shorten the operation time (efficacy), and to increase the quality of care (safety).
This pilot study aims at observing these aims on a small patient population and a control group.
Number of Subjects:
140 patients total in 6 groups:
* MitraClip, Left Atrial Appendage Closure or catheter Ablation with EchoNav (20, lead-in stage).
* MitraClip randomized with EchoNav (25), MitraClip randomized without EchoNav (25).
* TAVI with HeartNavigator lead in (10)
* TAVI randomized with HeartNavigator (30), TAVI randomized without HeartNavigator (30).
Goal of the study is to investigate the potential benefit that transcatheter interventions such as Transcatheter Aortic Valve Implantation (TAVI), MitraClip, Left Atrial Appendage Closure and catheter Ablation can gain from multimodal image fusion techniques as they are available in the Hybrid suite.
Both the HeartNavigator and the EchoNav aim at decreasing the exposure to radiation and contrast agent, to shorten the operation time (efficacy), and to increase the quality of care (safety).
This pilot study aims at observing these aims on a small patient population and a control group.
Number of Subjects:
140 patients total in 6 groups:
* MitraClip, Left Atrial Appendage Closure or catheter Ablation with EchoNav (20, lead-in stage).
* MitraClip randomized with EchoNav (25), MitraClip randomized without EchoNav (25).
* TAVI with HeartNavigator lead in (10)
* TAVI randomized with HeartNavigator (30), TAVI randomized without HeartNavigator (30).
Detailed Description:
Medical Device:
HeartNavigator: System for preoperative image-based assessment of aortic root geometry, planning of transcatheter aortic valve implantation, and intraoperative C-Arm control.
EchoNav: System for intraoperative registration of 3D Echo images with X-ray fluoroscopy images.
HeartNavigator: System for preoperative image-based assessment of aortic root geometry, planning of transcatheter aortic valve implantation, and intraoperative C-Arm control.
EchoNav: System for intraoperative registration of 3D Echo images with X-ray fluoroscopy images.
Study Oversight
Has Oversight DMC:
True
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?: