NCT04691245

3D US Guided Femoral Artery Access for TAVI

Three Dimensional Ultrasound Guided Femoral Access for Transcatheter Aortic Valve Implantation

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 104 (estimated)
• Sponsor: Catharina Ziekenhuis Eindhoven · Academic / Other
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Ultrasound Therapy; Complications
• Femoral Artery Injury

Interventions

Type	Name	Description
DEVICE	3D US	3D US guided access to femoral artery
DEVICE	2D US	2D US guided access to femoral artery

Timeline

• Start date: 2021-02-01
• Primary completion: 2021-09-01
• Completion: 2021-12-01
• First posted: 2020-12-31
• Last updated: 2020-12-31

Locations

1 site across 1 country: Netherlands

Regulatory

• FDA-regulated device study