3D US Guided Femoral Artery Access for TAVI

Not Applicable

• Conditions: Ultrasound Therapy; Complications; Femoral Artery Injury
• Interventions: Device: 3D US; Device: 2D US

• Registration Number: NCT04691245
• Lead Sponsor: Catharina Ziekenhuis Eindhoven

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2020-12
• Study First Submitted: 2020-12-20
• Study First Submitted QC: 2020-12-30
• Last Update Submitted: 2020-12-30
• Study First Posted: 2020-12-31
• Last Update Posted: 2020-12-31
• Study Start: 2021-02
• Primary Completion: 2021-09
• Study Completion: 2021-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 104

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention	3D US	Femoral access using 3D US
Control	2D US	Femoral access using 2D US

Primary Outcome Measures

Name	Time	Method
first pass success	during procedure/surgery	successful entry in femoral artery within one skinbreak and without needle redirections

Secondary Outcome Measures

Name	Time	Method
imaging time	during procedure/surgery	time from putting probe on skin to start procedure (in seconds)
procedure time	during procedure/surgery	time from puncturing skin until entry in femoral artery (in seconds)
12 o clock entry	during procedure/surgery	entrance to femoral artery at exactly 12 o clock (antero-medial)
total number of punctures	during procedure/surgery	new skin breaks needed for completion of procedure
number of needle redirections	during procedure/surgery	total number of needle withdrawals \>5mm but without needing new skin puncture
operator satisfaction	during procedure/surgery	likert scale 1-5 with 1 no satisfaction and 5 completely satisfied
needle visualization	during procedure/surgery	rated from good-adequate-poor

Trial Locations

Locations (1)

Catharina Ziekenhuis Eindhoven; 🇳🇱 Eindhoven, Noord-Brabant, Netherlands