Atrial Fibrillation Clinical Trial
Official title:
Ultrasound-guided or Anatomical Femoral Venipuncture for Pulmonary Vein Isolation for Atrial Fibrillation Treatment
This study is designed to evaluate the use of real-time ultrasound-guided femoral venipuncture during pulmonary vein isolation for treating atrial fibrillation .
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.
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