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

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 .

Study Overview

• Status: Completed
• Conditions: Atrial Fibrillation; Peripheral Vascular Disease; Vascular Access Complications
• Intervention / Treatment: Device: Real-time ultrasound-guided puncture; Other: Anatomical landmark guided puncture

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 Type: Interventional
• Enrollment (Actual): 320
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Czechia
  • Liberec, Czechia, 46001
    • Regional Hospital Liberec
  • Prague, Czechia, 16902
    • Ustredni vojenska nemocnice
  • Prague 4, Czechia, 14021
    • Institute for Clinical and Experimental Medicine
• Japan
  • Tokyo, Japan, 166-8588
    • Kawakita General Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Kenichiro Yamagata
• Investigators: Study Director: Joseph Kautzner, MD, PhD, Institute for Clinical and Experimental Medicine

Publications and helpful links

General Publications

• 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.

Helpful Links

• Pulished in Europace

Study record dates

Study Major Dates

• Study Start: June 1, 2016
• Primary Completion (Actual): November 1, 2016
• Study Completion (Actual): November 1, 2016

Study Registration Dates

• First Submitted: June 29, 2016
• First Submitted That Met QC Criteria: July 14, 2016
• First Posted (Estimate): July 15, 2016

Study Record Updates

• Last Update Posted (Actual): June 7, 2017
• Last Update Submitted That Met QC Criteria: June 6, 2017
• Last Verified: June 1, 2017

More Information

Terms related to this study

• Keywords: Femoral vein puncture
• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Atherosclerosis; Arrhythmias, Cardiac; Vascular Diseases; Peripheral Arterial Disease; Peripheral Vascular Diseases; Atrial Fibrillation
• Other Study ID Numbers: ULTRA-FAST

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO