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

Catharina Hospital

Status: Unknown

Conditions: Ultrasound Therapy; Complications; Femoral Artery Injury

Treatments: Device: 3D US; Device: 2D US

Study type: Interventional

Funder types: Other

Identifiers

NCT04691245

3D-US-TAVI

Details and patient eligibility

About

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.

Enrollment: 104 estimated patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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104 participants in 2 patient groups

Intervention

Experimental group

Description:

Femoral access using 3D US

Treatment:

Device: 3D US

Control

Active Comparator group

Description:

Femoral access using 2D US

Treatment:

Device: 2D US