Currently available antiarrhythmic drugs for the treatment of atrial fibrillation (AF) have a limited efficacy and often cause long-term side effects. Pulmonary vein isolation is the therapy of choice in drug-refractory patients. Recent studies have shown that ablation have a greater efficacy in patients in whom AF is maintained hierarchically and after ablation of rotors. The non-invasive identification of specific mechanism of AF maintenance in each patient could allow the selection of the most appropriate treatment.
The MAIN GOAL of this project is to clinically validate the technology for the noninvasive identification of the mechanisms responsible for maintenance of AF by body surface electrical mapping. To achieve this goal, noninvasive mapping of the atrial activity will be correlated with simultaneous endocardial mapping (high density contact catheters) using advanced signal analyses techniques (Dominant frequency, phase and causality mapping, inverse solution problem). These analyses will be performed in patients with different mechanisms of maintenance of AF (e.g. paroxysmal, persistent, valvular) undergoing AF ablation for clinical indication. Both endocardial and body surface mapping results will be correlated with biomarkers levels, MRI scans and AF outcomes of AF ablation at 6 months and 1 year after the procedure. Wide antrum circumferential pulmonary vein isolation with demonstration of bidirectional block will be performed using standard cooled-tip radiofrequency catheters. In patients with mitral stenosis, PBMV will be performed according to Inoue´s technique followed by wide antrum circumferential pulmonary vein isolation. In all patients, MRI/CT scans and fibrosis biomarkers will be obtained at baseline, 6 months and 1 year post ablation.
Study Type
OBSERVATIONAL
Enrollment
50
Simultaneous biatrial endocardial electroanatomical mapping by high-density basket catheter (64 pin) and customized body surface mapping (57 electrodes) followed by circumferential pulmonary vein ablation.
Felipe Atienza Fernandez
Madrid, Spain
Freedom from atrial fibrillation off antiarrhythmic medications in patients with either paroxysmal, persistent AF or valvular stenosis AF.
Time frame: 12 months post-first ablation procedure
Freedom from atrial fibrillation on or off antiarrhythmic medication post-first ablation procedure and after redo procedures.
Time frame: at 6 and 12 months
Freedom from atrial fibrillation and other atrial arrhythmias post-first ablation procedure and after redo procedures.
Time frame: at 6 and 12 months
Incidence of peri-procedural complications
Time frame: during ablation procedure and 12 months after
Procedure duration
Time frame: Duration of ablation procedure, and valvuloplasty if indicated, in minutes
Body surface recording analysis by 120 disposable electrodes distributed over the patient's chest and connected to the polygraph.
Time frame: During ablation procedure, and valvuloplasty if indicated
Electroanatomic reconstruction and recordings of electrical activity: a three-dimensional reconstruction of atrium and coronary sinus is obtained using high density catheters and an electroanatomic navigation system.
Time frame: During ablation procedure, and valvuloplasty if indicated
Atrial fibrosis determination using late gadolinium enhancement-MRI
Time frame: At 6 and 12 months
Fluoroscopy time
Time frame: During ablation procedure, and valvuloplasty if indicated, in minutes
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