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

Not Applicable

Completed

• Conditions: Atrial Fibrillation; Peripheral Vascular Disease; Vascular Access Complications
• Interventions: Other: Anatomical landmark guided puncture; Device: Real-time ultrasound-guided puncture

• Registration Number: NCT02834221
• Lead Sponsor: Kenichiro Yamagata

Brief Summary

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

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.

Study Timeline

• Study Start: 2016-06
• Study First Submitted: 2016-06-29
• Study First Submitted QC: 2016-07-14
• Study First Posted: 2016-07-15
• Primary Completion: 2016-11
• Study Completion: 2016-11
• Status Verified: 2017-06
• Last Update Submitted: 2017-06-06
• Last Update Posted: 2017-06-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 320

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Anatomical landmark guided puncture	Anatomical landmark guided puncture	Cannulate each femoral veins with two wires with the anatomical landmark guided method.
Real-time ultrasound-guided puncture	Real-time ultrasound-guided puncture	Cannulate each femoral veins with two wires with real-time ultrasound-guided method.

Primary Outcome Measures

Name	Time	Method
Major complications	After the puncture up to 12 weeks	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.

Secondary Outcome Measures

Name	Time	Method
Number of puncture attempts	Immediately after the puncture	Number of puncture attempts to cannulate all wires.
Total puncture time	Immediately after the puncture	Time from giving anesthesia to the groin till confirming all wires in the infra vena cava with the X-ray.
Unsuccessful femoral vein cannulation	Immediately after the puncture	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.
Number of artery mis-punctures	Immediately after the puncture	Number of artery mis-punctures attempts to cannulate all wires.
Use of X-ray for successful wire cannulation	Immediately after the puncture	If there is a need of X-ray to cannulate the wire into the infra vena cava.

Trial Locations

Locations (4)

Kawakita General Hospital; 🇯🇵 Tokyo, Japan

Ústřední vojenská nemocnice; 🇨🇿 Prague, Czechia

Regional Hospital Liberec; 🇨🇿 Liberec, Czechia

Institute for Clinical and Experimental Medicine; 🇨🇿 Prague 4, Czechia