Reduction of Fluoroscopy Exposure During Atrial Fibrillation Ablation (AF-FII)

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

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

Study Overview

• Status: Completed
• Conditions: Atrial Fibrillation
• Intervention / Treatment: Device: Radio-frequency catheter ablation

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 80
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • Saxony
    • Dresden, Saxony, Germany, 01307
      • Department of Electrophysiology, University of Dresden - Heart Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: CARTOUNIVU; Radiofrequency catheter ablation of atrial fibrillation will be performed using fluoroscopy image integrated 3-dimentional electroanatomical mapping system	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.
Active Comparator: CARTO3; Radiofrequency catheter ablation of atrial fibrillation will be performed using 3-dimentional electroanatomical mapping system without fluoroscopy image integration technique	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.
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)
Total time of atrial fibrillation ablation procedure as a measure of efficacy	procedure time (minute)	up to 24 hours

Collaborators and Investigators

• Sponsor: Technische Universität Dresden
• Collaborators: Biosense Webster, Inc.
• Investigators: Principal Investigator: Christopher Piorkowski, M.D., Department of Electrophysiology, University of Dresden - Heart Center

Study record dates

Study Major Dates

• Study Start: March 1, 2014
• Primary Completion (Actual): September 1, 2014
• Study Completion (Actual): September 1, 2014

Study Registration Dates

• First Submitted: May 2, 2014
• First Submitted That Met QC Criteria: May 13, 2014
• First Posted (Estimate): May 14, 2014

Study Record Updates

• Last Update Posted (Estimate): October 9, 2014
• Last Update Submitted That Met QC Criteria: October 7, 2014
• Last Verified: October 1, 2014

More Information

Terms related to this study

• Keywords: fluoroscopy; Atrial Fibrillation Ablation; fluoroscopy exposure; paroxysmal atrial fibrillation Ablation
• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac; Atrial Fibrillation
• Other Study ID Numbers: EK474122013; CARTOUNIVU (Other Grant/Funding Number: Biosense Webster)