Clinical trial NCT02834221: Ultrasound-guided Femoral Vein Accessibility, Safety and Time for Atrial Fibrillation Treatment
Official title: Ultrasound-guided or Anatomical Femoral Venipuncture for Pulmonary Vein Isolation for Atrial Fibrillation Treatment
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Atrial Fibrillation
Peripheral Vascular Disease
Vascular Access Complications
Keywords: Femoral vein puncture
Lead sponsor: Institute for Clinical and Experimental Medicine
Sponsor class: OTHER_GOV
First posted: 2016-07-15
Enrollment: 320
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Major complications
timeFrame: After the puncture up to 12 weeks
Secondary outcomes:
measure: Unsuccessful femoral vein cannulation
timeFrame: Immediately after the puncture
measure: Number of puncture attempts
timeFrame: Immediately after the puncture
measure: Total puncture time
timeFrame: Immediately after the puncture
measure: Number of artery mis-punctures
timeFrame: Immediately after the puncture
measure: Use of X-ray for successful wire cannulation
timeFrame: Immediately after the puncture
Other outcomes:
Locations:
city: Liberec
country: Czechia
facility: Regional Hospital Liberec
city: Prague 4
country: Czechia
facility: Institute for Clinical and Experimental Medicine
city: Prague
country: Czechia
facility: Ústřední vojenská nemocnice
city: Tokyo
country: Japan
facility: Kawakita General Hospital
Study officials:
affiliation: Institute for Clinical and Experimental Medicine
name: Joseph Kautzner, MD, PhD
role: STUDY_DIRECTOR
References:
citation: Yamagata K, Wichterle D, Roubicek T, Jarkovsky P, Sato Y, Kogure T, Peichl P, Konecny P, Jansova H, Kucera P, Aldhoon B, Cihak R, Sugimura Y, Kautzner J. Ultrasound-guided versus conventional femoral venipuncture for catheter ablation of atrial fibrillation: a multicentre randomized efficacy and safety trial (ULTRA-FAST trial). Europace. 2018 Jul 1;20(7):1107-1114. doi: 10.1093/europace/eux175.