3D US Guided Femoral Artery Access for TAVI

Ultrasound Therapy; Complications Clinical Trial

— 3D-US-TAVI  

Official title:

Three Dimensional Ultrasound Guided Femoral Access for Transcatheter Aortic Valve Implantation

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04691245
• Other study ID #: 3D-US-TAVI
• Status: Not yet recruiting
• Phase: N/A
• Start date: February 2021
• Est. completion date: December 2021

Study information

• Verified date: December 2020
• Source: Catharina Ziekenhuis Eindhoven
• Contact: Harm Scholten, MD
• Phone: 0031402398500
• Email: harm.scholten[@]cze.nl
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 104
• Est. completion date: December 2021
• Est. primary completion date: September 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Femoral Artery Injury
• Ultrasound Therapy; Complications

Intervention

Device:
• 3D US
3D US guided access to femoral artery
• 2D US
2D US guided access to femoral artery

Locations

Country	Name	City	State
Netherlands	Catharina Ziekenhuis Eindhoven	Eindhoven	Noord-Brabant

Sponsors (2)

Lead Sponsor	Collaborator
Catharina Ziekenhuis Eindhoven	Eindhoven University of Technology

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	first pass success	successful entry in femoral artery within one skinbreak and without needle redirections	during procedure/surgery
Secondary	imaging time	time from putting probe on skin to start procedure (in seconds)	during procedure/surgery
Secondary	procedure time	time from puncturing skin until entry in femoral artery (in seconds)	during procedure/surgery
Secondary	total number of punctures	new skin breaks needed for completion of procedure	during procedure/surgery
Secondary	number of needle redirections	total number of needle withdrawals >5mm but without needing new skin puncture	during procedure/surgery
Secondary	12 o clock entry	entrance to femoral artery at exactly 12 o clock (antero-medial)	during procedure/surgery
Secondary	needle visualization	rated from good-adequate-poor	during procedure/surgery
Secondary	operator satisfaction	likert scale 1-5 with 1 no satisfaction and 5 completely satisfied	during procedure/surgery