Cardiac Imaging Techniques
Conditions
Keywords
3D-Ultrasound, Live X-rays, EchoNavigator System
Brief 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.
Interventions
DEVICEData analysis
data parameters Analysis
Sponsors
Heinrich-Heine University, Duesseldorf
Study design
Observational model
OTHER
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Adult male or female patients of any ethnic origin aged \> 18 years * Signed and dated informed consent for the prospective study part
Exclusion criteria
* \< 18 year
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Comparison of procedure time | baseline | During interventions with and without the use of EchoNavigator System Release II |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Comparison of duration of the transeptal punction | baseline | During mitraClip implantations, ASD/PFO with and without the use of EchoNavigator System Release II. |
| Comparison of area dose product | baseline | During procedures with and without the use of EchoNavigator System Release II |
| Comparison of contrast agent amount | baseline | During procedures with and without the use of EchoNavigator System Release II |
| Comparison of data measurements of fluoroscopy time | baseline | During procedures with and without the use of EchoNavigator System Release II |
Countries
Germany
Outcome results
None listed