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

Atrial Fibrillation Clinical Trial

— ULTRA-FAST  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02834221
• Other study ID #: ULTRA-FAST
• Status: Completed
• Phase: N/A
• First received: June 29, 2016
• Last updated: June 6, 2017
• Start date: June 2016
• Est. completion date: November 2016

Study information

• Verified date: June 2017
• Source: Institute for Clinical and Experimental Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study is designed to evaluate the use of real-time ultrasound-guided femoral venipuncture during pulmonary vein isolation for treating atrial fibrillation .

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 320
• Est. completion date: November 2016
• Est. primary completion date: November 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Atrial Fibrillation
• Peripheral Arterial Disease
• Peripheral Vascular Disease
• Peripheral Vascular Diseases
• Vascular Access Complications
• Vascular Diseases

Intervention

Device:
• Real-time ultrasound-guided puncture
A 7 megahertz ultrasound linear probe will be used.

Other:
• Anatomical landmark guided puncture
Anatomical landmark puncture

Locations

Country	Name	City	State
Czechia	Regional Hospital Liberec	Liberec
Czechia	Ústrední vojenská nemocnice	Prague
Czechia	Institute for Clinical and Experimental Medicine	Prague 4
Japan	Kawakita General Hospital	Tokyo

Sponsors (1)

Lead Sponsor	Collaborator
Kenichiro Yamagata

Countries where clinical trial is conducted

Czechia,  Japan, 

References & Publications (1)

Yamagata K, Wichterle D, Roubícek T, Jarkovský P, Sato Y, Kogure T, Peichl P, Konecný P, Jansová H, Kucera P, Aldhoon B, Cihák R, Sugimura Y, Kautzner J. Ultrasound-guided versus conventional femoral venipuncture for catheter ablation of atrial fibrillati — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	Number of puncture attempts	Number of puncture attempts to cannulate all wires.	Immediately after the puncture
Secondary	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
Secondary	Number of artery mis-punctures	Number of artery mis-punctures attempts to cannulate all wires.	Immediately after the puncture
Secondary	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

External Links

•   Pulished in Europace