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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Data analysis transfemoral aortic valve implantation | Periinterventional data analysis during structural heart procedures like transfemoral aortic valve implantation with and without the use of EchoNavigator System Release II. |
| |
| Data analysis MitraClip | Periinterventional data analysis during structural heart procedures like MitraClip Implantations with and without the use of EchoNavigator System Release II. |
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| Data analysis PFO | Periinterventional data analysis during structural heart procedures like PFO implantations with and without the use of EchoNavigator System Release II. |
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| Data analysis ASD | Periinterventional data analysis during structural heart procedures like ASD implantations with and without the use of EchoNavigator System Release II. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Data analysis | Device | data parameters Analysis |
|
| Measure | Description | Time Frame |
|---|---|---|
| Comparison of procedure time | During interventions with and without the use of EchoNavigator System Release II | baseline |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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Adult male or female patients undergoing structural heart interventions like transfemoral aortic valve Implantation (TAVI), MitraClip implantation, patent foramen ovale (PFO), atrial septal defect (ASD) and left atrial appendage (LAA) with or without the periintervention use of the EchoNavigator System Release II.
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| Name | Affiliation | Role |
|---|---|---|
| Malte Kelm, MD | Division of Cardiology, Pulmonary Disease and Vascular Medicine | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Division of Cardiology, Pulmonary Disease and Vascular Medicine | Düsseldorf | 40225 | Germany |
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| 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 |