Reduction of Fluoroscopy Exposure During Atrial Fibrillation Ablation (AF-FII)
Primary Purpose
Atrial Fibrillation
Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Radio-frequency catheter ablation
Sponsored by
About this trial
This is an interventional prevention trial for Atrial Fibrillation focused on measuring fluoroscopy exposure, paroxysmal atrial fibrillation Ablation, fluoroscopy, Atrial Fibrillation Ablation
Eligibility Criteria
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
Sites / Locations
- Department of Electrophysiology, University of Dresden - Heart Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
CARTOUNIVU
CARTO3
Arm Description
Radiofrequency catheter ablation of atrial fibrillation will be performed using fluoroscopy image integrated 3-dimentional electroanatomical mapping system
Radiofrequency catheter ablation of atrial fibrillation will be performed using 3-dimentional electroanatomical mapping system without fluoroscopy image integration technique
Outcomes
Primary Outcome Measures
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.
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.
Secondary Outcome Measures
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.
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
Total time of atrial fibrillation ablation procedure as a measure of efficacy
procedure time (minute)
Full Information
NCT ID
NCT02137798
First Posted
May 2, 2014
Last Updated
October 7, 2014
Sponsor
Technische Universität Dresden
Collaborators
Biosense Webster, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT02137798
Brief Title
Reduction of Fluoroscopy Exposure During Atrial Fibrillation Ablation
Acronym
AF-FII
Official Title
Atrial Fibrillation Ablation Facilitated by Fluoroscopy Image Integrated 3-dimentional Electroanatomical Mapping System
Study Type
Interventional
2. Study Status
Record Verification Date
October 2014
Overall Recruitment Status
Completed
Study Start Date
March 2014 (undefined)
Primary Completion Date
September 2014 (Actual)
Study Completion Date
September 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Technische Universität Dresden
Collaborators
Biosense Webster, Inc.
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief 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
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atrial Fibrillation
Keywords
fluoroscopy exposure, paroxysmal atrial fibrillation Ablation, fluoroscopy, Atrial Fibrillation Ablation
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
80 (Actual)
8. Arms, Groups, and Interventions
Arm Title
CARTOUNIVU
Arm Type
Experimental
Arm Description
Radiofrequency catheter ablation of atrial fibrillation will be performed using fluoroscopy image integrated 3-dimentional electroanatomical mapping system
Arm Title
CARTO3
Arm Type
Active Comparator
Arm Description
Radiofrequency catheter ablation of atrial fibrillation will be performed using 3-dimentional electroanatomical mapping system without fluoroscopy image integration technique
Intervention Type
Device
Intervention Name(s)
Radio-frequency catheter ablation
Intervention Description
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.
Primary Outcome Measure Information:
Title
Fluoroscopy time for each step of atrial fibrillation ablation procedure
Description
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.
Time Frame
1 day ( at the end of each step of atrial fibrillation ablation procedure)
Title
Fluoroscopy doses for each step of atrial fibrillation ablation procedure
Description
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.
Time Frame
1 day ( at the end of each step of atrial fibrillation ablation procedure)
Secondary Outcome Measure Information:
Title
Number of patients with adverse events as a measure of safety
Description
Perforation, tamponed, phrenic nerve injury and oesophagus injury (patients will be screened for oesophagus injury for a month after atrial fibrillation ablation), etc.
Time Frame
All patients will be followed for the duration of hospital stay for acute complications, an expected average of 3 days.
Title
Number of patients with a failure of reaching endpoints of procedure as a measure of efficacy
Description
number of pulmonary veins/linear ablation lines has not been completely isolated/blocked at the end of the AF ablation
Time Frame
1 day ( at the end of each step of atrial fibrillation ablation procedure)
Title
Total time of atrial fibrillation ablation procedure as a measure of efficacy
Description
procedure time (minute)
Time Frame
up to 24 hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christopher Piorkowski, M.D.
Organizational Affiliation
Department of Electrophysiology, University of Dresden - Heart Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Electrophysiology, University of Dresden - Heart Center
City
Dresden
State/Province
Saxony
ZIP/Postal Code
01307
Country
Germany
12. IPD Sharing Statement
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Reduction of Fluoroscopy Exposure During Atrial Fibrillation Ablation
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