3D US Guided Femoral Artery Access for TAVI

Study Overview
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Brief Summary
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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.

Official Title
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Three Dimensional Ultrasound Guided Femoral Access for Transcatheter Aortic Valve Implantation

Conditions
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Ultrasound Therapy; Complications, Femoral Artery Injury

Intervention / Treatment
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* Device: 3D US
* Device: 2D US


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adult age (>18 years) Scheduled to undergo elective transcatheter aortic valve implantation with percutaneous access through the femoral artery Written Informed consent Exclusion Criteria: Unable to obtain informed consent Vascular access via alternative approach (radial/subclavian) or surgical cutdown

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: randomized clinical trial with two arms
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention<br>Femoral access using 3D US | Device: 3D US<br>* 3D US guided access to femoral artery<br>|
| Active Comparator: Control<br>Femoral access using 2D US | Device: 2D US<br>* 2D US guided access to femoral artery<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| first pass success | successful entry in femoral artery within one skinbreak and without needle redirections | during procedure/surgery | 

Secondary Outcome Measures

| Outcome Measure | 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) | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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3D Ultrasound, vascular access, Transcatheter aortic valve implantation