Ultrasound-guided Femoral Vein Accessibility, Safety and Time for Atrial Fibrillation Treatment
NCT ID: NCT02834221
Last Updated: 2017-06-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
320 participants
INTERVENTIONAL
2016-06-30
2016-11-30
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
SINGLE
Study Groups
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Real-time ultrasound-guided puncture
Cannulate each femoral veins with two wires with real-time ultrasound-guided method.
Real-time ultrasound-guided puncture
A 7 megahertz ultrasound linear probe will be used.
Anatomical landmark guided puncture
Cannulate each femoral veins with two wires with the anatomical landmark guided method.
Anatomical landmark guided puncture
Anatomical landmark puncture
Interventions
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Real-time ultrasound-guided puncture
A 7 megahertz ultrasound linear probe will be used.
Anatomical landmark guided puncture
Anatomical landmark puncture
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
ALL
No
Sponsors
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Kenichiro Yamagata
OTHER_GOV
Responsible Party
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Kenichiro Yamagata
MD, PhD
Principal Investigators
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Joseph Kautzner, MD, PhD
Role: STUDY_DIRECTOR
Institute for Clinical and Experimental Medicine
Locations
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Regional Hospital Liberec
Liberec, , Czechia
Institute for Clinical and Experimental Medicine
Prague, , Czechia
Ústřední vojenská nemocnice
Prague, , Czechia
Kawakita General Hospital
Tokyo, , Japan
Countries
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References
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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.
Other Identifiers
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ULTRA-FAST
Identifier Type: -
Identifier Source: org_study_id
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