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3D US Guided Femoral Artery Access for TAVI

NCT ID: NCT04691245

Last Updated: 2020-12-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

104 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-02-28

Study Completion Date

2021-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Ultrasound Therapy; Complications Femoral Artery Injury

Keywords

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3D Ultrasound vascular access Transcatheter aortic valve implantation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

randomized clinical trial with two arms
Primary Study Purpose

OTHER

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Intervention

Femoral access using 3D US

Group Type EXPERIMENTAL

3D US

Intervention Type DEVICE

3D US guided access to femoral artery

Control

Femoral access using 2D US

Group Type ACTIVE_COMPARATOR

2D US

Intervention Type DEVICE

2D US guided access to femoral artery

Interventions

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3D US

3D US guided access to femoral artery

Intervention Type DEVICE

2D US

2D US guided access to femoral artery

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Eindhoven University of Technology

OTHER

Sponsor Role collaborator

Catharina Ziekenhuis Eindhoven

OTHER

Sponsor Role lead

Responsible Party

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Harm Scholten

md

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Catharina Ziekenhuis Eindhoven

Eindhoven, North Brabant, Netherlands

Site Status

Countries

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Netherlands

Central Contacts

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Harm Scholten, MD

Role: CONTACT

Phone: 0031402398500

Email: [email protected]

Arthur Bouwman, PhD

Role: CONTACT

Phone: 0031402398500

Email: [email protected]

Facility Contacts

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Harm Scholten, MSc

Role: primary

Other Identifiers

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3D-US-TAVI

Identifier Type: -

Identifier Source: org_study_id