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3D US Guided Femoral Artery Access for TAVI

NCT04691245 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 104

Last updated 2020-12-31

No results posted yet for this study

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

DEVICE

3D US

3D US guided access to femoral artery

DEVICE

2D US

2D US guided access to femoral artery

Sponsors & Collaborators

  • Eindhoven University of Technology

    collaborator OTHER

  • Catharina Ziekenhuis Eindhoven

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-02-28
Primary Completion
2021-09-30
Completion
2021-12-31
FDA Device
Yes

Countries

  • Netherlands

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04691245 on ClinicalTrials.gov