Ultrasound-guided Femoral Vein Accessibility, Safety and Time for Atrial Fibrillation Treatment

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

Detailed Description
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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.

Official Title
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Ultrasound-guided or Anatomical Femoral Venipuncture for Pulmonary Vein Isolation for Atrial Fibrillation Treatment

Conditions
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Atrial Fibrillation, Peripheral Vascular Disease, Vascular Access Complications

Intervention / Treatment
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* Device: Real-time ultrasound-guided puncture
* Other: Anatomical landmark guided puncture


Participation Criteria
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Eligibility Criteria
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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.
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Real-time ultrasound-guided puncture<br>Cannulate each femoral veins with two wires with real-time ultrasound-guided method. | Device: Real-time ultrasound-guided puncture<br>* A 7 megahertz ultrasound linear probe will be used.<br>|
| Other: Anatomical landmark guided puncture<br>Cannulate each femoral veins with two wires with the anatomical landmark guided method. | Other: Anatomical landmark guided puncture<br>* Anatomical landmark puncture<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Major complications | Total patient number of vascular complications requiring surgical treatment, retroperitoneal hematoma requiring blood transfusion or hemoglobin drop of 3 >g/dl, strong pain at the groin, prolonging hospital stay and requiring hospital admission after discharge. | After the puncture up to 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Unsuccessful femoral vein cannulation | Number of patients with unsuccessful femoral vein cannulation defined as crossing over to the other randomized method or change of operator to cannulate all wires. | Immediately after the puncture | 
| Number of puncture attempts | Number of puncture attempts to cannulate all wires. | Immediately after the puncture | 
| Total puncture time | Time from giving anesthesia to the groin till confirming all wires in the infra vena cava with the X-ray. | Immediately after the puncture | 
| Number of artery mis-punctures | Number of artery mis-punctures attempts to cannulate all wires. | Immediately after the puncture | 
| Use of X-ray for successful wire cannulation | If there is a need of X-ray to cannulate the wire into the infra vena cava. | Immediately after the puncture | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Femoral vein puncture