NCT02608008

Safety and Efficacy of EchoNavigator System Release II During Structural Heart Interventions

Safety and Efficacy of EchoNavigator System Release II (Philips, Andover, MA) During Structural Heart Interventions

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 500 (estimated)
• Sponsor: Heinrich-Heine University, Duesseldorf · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to collect data regarding the safety and efficacy of EchoNavigator System Release II during structural heart interventions in the clinical practice. Data of procedures with and without the use of EchoNavigator System Release II will be collected, analysed and evaluated.

Detailed description

EchoNavigator System Release II is a CE certified innovative periinterventional imaging modality used in our clinic of cardiology, pulmonology and angiology during structural heart interventions like transfemoral aortic valve Implantation (TAVI), MitraClip implantation, patent foramen ovale (PFO), atrial septal defect (ASD) and left atrial appendage (LAA). During this interventions EchoNavigator is able to combine live X-ray Images and 3D Echo guidance to enhance the efficiency of the procedure. Specific periprocedural data parameter, e.g. procedure duration, radiation time, radiation dose, transseptal punction time (e.g.LAA) and contrast agent amount will be collected and analysed. The same data characteristics from the same procedures but without the periinterventional use of the EchoNavigator System Release II will be collected, analysed and compared with the data described above. A retrospective data collection between 2013 - 2017 of n=500 patients will be conducted.

Conditions

• Cardiac Imaging Techniques

Interventions

Type	Name	Description
DEVICE	Data analysis	data parameters Analysis

Timeline

• Start date: 2014-09-01
• Primary completion: 2018-12-31
• Completion: 2021-06-01
• First posted: 2015-11-18
• Last updated: 2021-02-16

Locations

1 site across 1 country: Germany