Clinical trial NCT02137798: Reduction of Fluoroscopy Exposure During Atrial Fibrillation Ablation
Official title: Atrial Fibrillation Ablation Facilitated by Fluoroscopy Image Integrated 3-dimentional Electroanatomical Mapping System
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Atrial Fibrillation
Keywords: fluoroscopy exposure
paroxysmal atrial fibrillation Ablation
fluoroscopy
Atrial Fibrillation Ablation
Lead sponsor: Technische Universität Dresden
Sponsor class: OTHER
Collaborators: name: Biosense Webster, Inc.
First posted: 2014-05-14
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: Fluoroscopy time for each step of atrial fibrillation ablation procedure
timeFrame: 1 day ( at the end of each step of atrial fibrillation ablation procedure)
measure: Fluoroscopy doses for each step of atrial fibrillation ablation procedure
timeFrame: 1 day ( at the end of each step of atrial fibrillation ablation procedure)
Secondary outcomes:
measure: Number of patients with adverse events as a measure of safety
timeFrame: All patients will be followed for the duration of hospital stay for acute complications, an expected average of 3 days.
measure: Number of patients with a failure of reaching endpoints of procedure as a measure of efficacy
timeFrame: 1 day ( at the end of each step of atrial fibrillation ablation procedure)
measure: Total time of atrial fibrillation ablation procedure as a measure of efficacy
timeFrame: up to 24 hours
Other outcomes:
Locations:
city: Dresden
country: Germany
facility: Department of Electrophysiology, University of Dresden - Heart Center
state: Saxony
Study officials:
affiliation: Department of Electrophysiology, University of Dresden - Heart Center
name: Christopher Piorkowski, M.D.
role: PRINCIPAL_INVESTIGATOR
References: