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Completed

NCT Number: NCT02834221

Ultrasound-guided Femoral Vein Accessibility, Safety and Time 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 .

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Key information

Conditions

Atrial Fibrillation Arrhythmias, Cardiac Cardiovascular Diseases Heart Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Peripheral Vascular Disease Peripheral Vascular Diseases Vascular Access Complications Vascular Diseases

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Regional Hospital Liberec, Liberec, Czechia

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Real-time ultrasound-guided puncture

Device

A 7 megahertz ultrasound linear probe will be used.

Anatomical landmark guided puncture

Other

Anatomical landmark puncture

Primary outcomes

  1. Major complications

    Time frame: 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 outcomes

  1. Unsuccessful femoral vein cannulation

    Time frame: 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.

  2. Number of puncture attempts

    Time frame: Immediately after the puncture

    Number of puncture attempts to cannulate all wires.

  3. Total puncture time

    Time frame: Immediately after the puncture

    Time from giving anesthesia to the groin till confirming all wires in the infra vena cava with the X-ray.

  4. Number of artery mis-punctures

    Time frame: Immediately after the puncture

    Number of artery mis-punctures attempts to cannulate all wires.

  5. Use of X-ray for successful wire cannulation

    Time frame: Immediately after the puncture

    If there is a need of X-ray to cannulate the wire into the infra vena cava.

Sponsors and collaborators

Lead sponsor

Kenichiro Yamagata

Other Gov

Registry information

Official study title

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

Acronym: ULTRA-FAST

Important dates

Study start
2016
Primary completion
2016
Study completion
2016
First posted
Jul 15, 2016
Registry last updated
Jun 7, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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