Reduction of Fluoroscopy Exposure During Atrial Fibrillation Ablation

Atrial Fibrillation Clinical Trial

— AF-FII  

Official title:

Atrial Fibrillation Ablation Facilitated by Fluoroscopy Image Integrated 3-dimentional Electroanatomical Mapping System

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02137798
• Other study ID #: EK474122013
• Secondary ID: CARTOUNIVU
• Status: Completed
• Phase: N/A
• First received: May 2, 2014
• Last updated: October 7, 2014
• Start date: March 2014
• Est. completion date: September 2014

Study information

• Verified date: October 2014
• Source: Technische Universität Dresden
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

To evaluate reduction of fluoroscopy time/dosis and safety of atrial fibrillation ablation in patients with paroxysmal atrial fibrillation using fluoroscopy image integrated 3-dimentional electroanatomical mapping system, comparing to using 3-dimentional electroanatomical mapping system without fluoroscopy image integration

Description:

The novel fluoroscopic image integrated 3-dimentional electroanatomical mapping system is designed for minimizing the exposure to X-ray for physician, staff and patients. This randomized single-center study is to evaluate the reduction on fluoroscopy levels (time and dosis) in catheter interventional treatment of symptomatic, antiarrhythmic refractory paroxysmal atrial fibrillation using fluoroscopic image integrated 3-dimentional electroanatomical mapping system, comparing with using 3-dimentional electroanatomical mapping system without fluoroscopic image integration. Patients with documented paroxysmal atrial fibrillation, who are going to receive a catheter interventional treatment to atrial fibrillation, will be randomized (1:1) into two groups after signing an informed consent. Group 1 (CARTOUNIVU): using fluoroscopic image integrated 3-dimentional electroanatomical mapping system. Group 2 (CARTO3): using 3-dimentional electroanatomical mapping system without fluoroscopic image integration.

The ablation strategies in both study groups are the same, including circumferential isolation of ipsilateral pulmonary veins (PV) and voltage map guided substrate modification. According to the randomization, the ablation procedure will be performed with or without fluoroscopic image integration.

The primary endpoint of this study is the evaluation of reduction on fluoroscopy levels (fluoroscopy time and dosis) during atrial fibrillation ablation procedure. Secondary endpoints include complete isolation of the pulmonary veins, completely bidirectional block of linear ablation lines, total procedure time, ablation-related complications.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: September 2014
• Est. primary completion date: September 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• documented atrial fibrillation in the 12-lead ECG or Holter ECG

• Paroxysmal symptomatic atrial fibrillation

• Ineffectiveness of antiarrhythmic medication ( at least 1 medication )

• Age 18-75 years

• left atrial diameter <60 mm ( Transesophageal Echocardiography, parasternal )

• A signed consent form

Exclusion Criteria:

• Reversible etiology of atrial fibrillation

• Pregnancy

• Women of childbearing potential without a negative pregnancy test within 48 hours prior to the ablation procedure

• Intracardiac thrombus

• Contraindication to anticoagulation

• Thromboembolic event in the last 6 months

• Previous left atrial ablation

Related Conditions & MeSH terms

• Atrial Fibrillation

Intervention

Device:
• Radio-frequency catheter ablation
Radio-frequency atrial fibrillation catheter ablation includes circumferential PV isolation and voltage-map guided substrate modification, which means low voltage zone (amplitude < o.5 mV) will also be ablated.

Locations

Country	Name	City	State
Germany	Department of Electrophysiology, University of Dresden - Heart Center	Dresden	Saxony

Sponsors (2)

Lead Sponsor	Collaborator
Technische Universität Dresden	Biosense Webster, Inc.

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Fluoroscopy time for each step of atrial fibrillation ablation procedure	Fluoroscopy time will be recorded at the end of each step of atrial fibrillation ablation, including femoral vein puncture, placement of catheters, transseptal puncture, system registration, reconstruction of left atrium, PV-Angiography, acquirement of voltage map, PV-isolation, confirmation of complete PV isolation and linear ablations.	1 day ( at the end of each step of atrial fibrillation ablation procedure)
Primary	Fluoroscopy doses for each step of atrial fibrillation ablation procedure	Fluoroscopy doses will be recorded at the end of each step of atrial fibrillation ablation, including femoral vein puncture, placement of catheters, transseptal puncture, system registration, reconstruction of left atrium, PV-Angiography, acquirement of voltage map, PV-isolation, confirmation of complete PV isolation and linear ablations.	1 day ( at the end of each step of atrial fibrillation ablation procedure)
Secondary	Number of patients with adverse events as a measure of safety	Perforation, tamponed, phrenic nerve injury and oesophagus injury (patients will be screened for oesophagus injury for a month after atrial fibrillation ablation), etc.	All patients will be followed for the duration of hospital stay for acute complications, an expected average of 3 days.
Secondary	Number of patients with a failure of reaching endpoints of procedure as a measure of efficacy	number of pulmonary veins/linear ablation lines has not been completely isolated/blocked at the end of the AF ablation	1 day ( at the end of each step of atrial fibrillation ablation procedure)
Secondary	Total time of atrial fibrillation ablation procedure as a measure of efficacy	procedure time (minute)	up to 24 hours