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| Name | Class |
|---|---|
| Eindhoven University of Technology | OTHER |
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Rationale: Bleeding and vascular complications of the femoral artery still account for significant morbidity and mortality in transcatheter aortic valve implantation procedures. Although steadily declining over the past years through smaller diameter devices and use of ultrasound, major complications still occur in 3-4 % of patients. Femoral access is often obtained using 2D US guidance already. New 3D US probes can aid in increasing anatomical awareness. This can improve first pass success during procedures. Furthermore, for new closure devices, entering the artery at a straight angle at precisely 12 o'clock probably reduces complications. Therefore, the investigators hypothesize improved real time needle guidance using three dimensional ultrasound can decrease procedure related complications.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention | Experimental | Femoral access using 3D US |
|
| Control | Active Comparator | Femoral access using 2D US |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 3D US | Device | 3D US guided access to femoral artery |
| |
| 2D US |
| Measure | Description | Time Frame |
|---|---|---|
| first pass success | successful entry in femoral artery within one skinbreak and without needle redirections | during procedure/surgery |
| Measure | Description | Time Frame |
|---|---|---|
| imaging time | time from putting probe on skin to start procedure (in seconds) | during procedure/surgery |
| procedure time | time from puncturing skin until entry in femoral artery (in seconds) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Harm Scholten, MD | Contact | 0031402398500 | 2211 | harm.scholten@cze.nl |
| Arthur Bouwman, PhD | Contact | 0031402398500 | 2208 | arthur.bouwman@cze.nl |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Catharina Ziekenhuis Eindhoven | Eindhoven | North Brabant | 5623 EJ | Netherlands |
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randomized clinical trial with two arms
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| Device |
2D US guided access to femoral artery |
|
| during procedure/surgery |
| total number of punctures | new skin breaks needed for completion of procedure | during procedure/surgery |
| number of needle redirections | total number of needle withdrawals >5mm but without needing new skin puncture | during procedure/surgery |
| 12 o clock entry | entrance to femoral artery at exactly 12 o clock (antero-medial) | during procedure/surgery |
| needle visualization | rated from good-adequate-poor | during procedure/surgery |
| operator satisfaction | likert scale 1-5 with 1 no satisfaction and 5 completely satisfied | during procedure/surgery |