Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 11:56 PM
Ignite Modification Date:
2025-12-24 @ 11:56 PM
NCT ID:
NCT01821651
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).
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.
Study:
NCT01821651
Study Brief:
Protocol Section:
NCT01821651