3D US Guided Femoral Artery Access for TAVI (3D-US-TAVI)

Three Dimensional Ultrasound Guided Femoral Access for Transcatheter Aortic Valve Implantation

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.

Study Overview

• Status: Unknown
• Conditions: Ultrasound Therapy; Complications; Femoral Artery Injury
• Intervention / Treatment: Device: 3D US; Device: 2D US

• Study Type: Interventional
• Enrollment (Anticipated): 104
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Netherlands
  • Noord-Brabant
    • Eindhoven, Noord-Brabant, Netherlands, 5623 EJ
      • Catharina Ziekenhuis Eindhoven

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: OTHER
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: TRIPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Intervention; Femoral access using 3D US	Device: 3D US; 3D US guided access to femoral artery
ACTIVE_COMPARATOR: Control; Femoral access using 2D US	Device: 2D US; 2D US guided access to femoral artery

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Catharina Ziekenhuis Eindhoven
• Collaborators: Eindhoven University of Technology

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): February 1, 2021
• Primary Completion (ANTICIPATED): September 1, 2021
• Study Completion (ANTICIPATED): December 1, 2021

Study Registration Dates

• First Submitted: December 20, 2020
• First Submitted That Met QC Criteria: December 30, 2020
• First Posted (ACTUAL): December 31, 2020

Study Record Updates

• Last Update Posted (ACTUAL): December 31, 2020
• Last Update Submitted That Met QC Criteria: December 30, 2020
• Last Verified: December 1, 2020

More Information

Terms related to this study

• Keywords: vascular access; Transcatheter aortic valve implantation; 3D Ultrasound
• Other Study ID Numbers: 3D-US-TAVI

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes