3D US Guided Femoral Artery Access for TAVI

NCT04691245 | Unknown FDA Device

• 1 other identifier: 3D-US-TAVI
• Study Type: interventional
• Target: 104
• Locations: 1 country
• Sites: 1

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.

Conditions

Ultrasound Therapy; Complications; Femoral Artery Injury

Keywords

3D Ultrasound; vascular access; Transcatheter aortic valve implantation

Outcome Measures

Primary Outcomes (1)

• first pass success

  successful entry in femoral artery within one skinbreak and without needle redirections

  during procedure/surgery

Secondary Outcomes (7)

• imaging time

  during procedure/surgery

• procedure time

  during procedure/surgery

• total number of punctures

  during procedure/surgery

• number of needle redirections

  during procedure/surgery

• 12 o clock entry

  during procedure/surgery

Study Arms (2)

Intervention

EXPERIMENTAL

Femoral access using 3D US

Device: 3D US

Control

ACTIVE COMPARATOR

Femoral access using 2D US

Device: 2D US

Interventions

3D US DEVICE

3D US guided access to femoral artery

Intervention

2D US DEVICE

2D US guided access to femoral artery

Control

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult age (\>18 years)
• Scheduled to undergo elective transcatheter aortic valve implantation with percutaneous access through the femoral artery
• Written Informed consent

You may not qualify if:

• Unable to obtain informed consent
• Vascular access via alternative approach (radial/subclavian) or surgical cutdown

Sponsors & Collaborators

• Catharina Ziekenhuis Eindhoven: lead
• Eindhoven University of Technology: collaborator

Study Sites (1)

Catharina Ziekenhuis Eindhoven

Eindhoven, North Brabant, 5623 EJ, Netherlands

Location

Central Study Contacts

Harm Scholten, MD

CONTACT

0031402398500; harm.scholten@cze.nl

Arthur Bouwman, PhD

CONTACT

0031402398500; arthur.bouwman@cze.nl

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: md

Model Details: randomized clinical trial with two arms

Study Record Dates

• First Submitted: December 20, 2020
• First Posted: December 31, 2020
• Study Start: February 1, 2021
• Primary Completion: September 1, 2021
• Study Completion: December 1, 2021
• Last Updated: December 31, 2020

Record last verified: 2020-12

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1)