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

Study Overview
=================
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.

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

Conditions
-----------------
Cardiac Imaging Techniques

Intervention / Treatment
-----------------
* Device: Data analysis


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Data analysis transfemoral aortic valve implantation<br>Periinterventional data analysis during structural heart procedures like transfemoral aortic valve implantation with and without the use of EchoNavigator System Release II. | Device: Data analysis<br>* data parameters Analysis<br>|
| Data analysis MitraClip<br>Periinterventional data analysis during structural heart procedures like MitraClip Implantations with and without the use of EchoNavigator System Release II. | Device: Data analysis<br>* data parameters Analysis<br>|
| Data analysis PFO<br>Periinterventional data analysis during structural heart procedures like PFO implantations with and without the use of EchoNavigator System Release II. | Device: Data analysis<br>* data parameters Analysis<br>|
| Data analysis ASD<br>Periinterventional data analysis during structural heart procedures like ASD implantations with and without the use of EchoNavigator System Release II. | Device: Data analysis<br>* data parameters Analysis<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comparison of procedure time | During interventions with and without the use of EchoNavigator System Release II | baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comparison of area dose product | During procedures with and without the use of EchoNavigator System Release II | baseline | 
| Comparison of contrast agent amount | During procedures with and without the use of EchoNavigator System Release II | baseline | 
| Comparison of data measurements of fluoroscopy time | During procedures with and without the use of EchoNavigator System Release II | baseline | 
| Comparison of duration of the transeptal punction | During mitraClip implantations, ASD/PFO with and without the use of EchoNavigator System Release II. | baseline | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
3D-Ultrasound, Live X-rays, EchoNavigator System