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The trial aims to evaluate the feasibility and safety of Caranx Medical TAVIPILOT augmented reality guidance software during Transcatheter Aortic Valve Replacement Procedures.
The study is a prospective mono-center single-arm study to evaluate primarily the feasibility and safety of TAVIPILOT augmented reality guidance software during Transcatheter Aortic Valve Replacement Procedures (TAVR) for severe aortic stenosis. A series of parameters will be analysed to determine whether TAVIPILOT is a safe tool for valve positioning.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TAVR procedure with TAVIPILOT (investigational medical device) | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TAVR using a guidance software | Device | TAVR procedure with TAVIPILOT augmented reality guidance software operating in parallel on a separate screen in a blind setup, enabling clinicians to assess the analysis and recommendations provided by the software, either immediately after valve deployment or following the completion of the procedure. |
| Measure | Description | Time Frame |
|---|---|---|
| Investigational Device Safety | Exploratory evaluation of the technical robustness of the Investigational Device (TaviPilot Software) by evaluating the occurence of malfunctions while operating passively in parallel of the clinical procedure | Peroperative |
| Measure | Description | Time Frame |
|---|---|---|
| Investigational Device Performance | Assess the performance of the device by comparing the valve implantation depth measured by the TaviPilot Software with the depth estimated by the investigator who performed the procedure. | Peroperative |
| Investigational Device Performance |
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Inclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Eric Sejor, MD | Contact | 0033673335594 | eric.sejor@caranx-medical.com |
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| ID | Term |
|---|---|
| D001024 | Aortic Valve Stenosis |
| ID | Term |
|---|---|
| D000082862 | Aortic Valve Disease |
| D006349 | Heart Valve Diseases |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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|
Assessment of clinician satisfaction related to device usability and performance using custom made questionnaires |
| Peroperative |
| D014694 |
| Ventricular Outflow Obstruction |