Ultrasound-guided Femoral Vein Accessibility, Safety and Time for Atrial Fibrillation Treatment (ULTRA-FAST)

Kenichiro Yamagata

Status: Completed

Conditions: Atrial Fibrillation; Peripheral Vascular Disease; Vascular Access Complications

Treatments: Other: Anatomical landmark guided puncture; Device: Real-time ultrasound-guided puncture

Study type: Interventional

Funder types: Other

Identifiers

NCT02834221

ULTRA-FAST

Details and patient eligibility

About

This study is designed to evaluate the use of real-time ultrasound-guided femoral venipuncture during pulmonary vein isolation for treating atrial fibrillation .

Full description

The number of pulmonary vein isolation (PVI) therapy for atrial fibrillation (AF) is increasing. Multiple femoral vein cannulation is mandatory for this procedure. There are mainly two methods to cannulate the femoral vein; by anatomical landmark or by under real-time ultrasound-guided. As high anticoagulant level is required for the procedure, there are 0-13% of vascular access complication.

Real-time ultrasound assistance for central venous catheter cannulation has been proven to reduce complications. In the field of AF treatment, multiple femoral vein cannulation is required as many catheter is required for the procedure and larger sheaths are inserted with a high anticoagulant level during the procedure. In this setting, the use of ultrasound use is not well studied.

The current study is to confirm whether real time ultrasound-guided femoral vein cannulation for PVI can prevent complications, reduce puncture time, puncture attempts and accidental artery puncture compared to conventional anatomical approach. Two seethes for each femoral vein is going to be cannulated.

The study design is a multicenter prospective randomized trial to compare the above safety and efficacy by using the ultrasound-guided and anatomical landmark approach. Also time for cannulation, number of puncture attempts, need of X-ray for cannulation will be analyzed in the setting of patient factors including age, body mass index and sex.

Enrollment: 320 patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients undergoing pulmonary vein isolation with radiofrequency catheter ablation for atrial fibrillation treatment.

Exclusion criteria

• Patients with prior known vascular access problems or priory included to the current study.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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320 participants in 2 patient groups

Real-time ultrasound-guided puncture

Experimental group

Description:

Cannulate each femoral veins with two wires with real-time ultrasound-guided method.

Treatment:

Device: Real-time ultrasound-guided puncture

Anatomical landmark guided puncture

Other group

Description:

Cannulate each femoral veins with two wires with the anatomical landmark guided method.

Treatment:

Other: Anatomical landmark guided puncture