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| Name | Class |
|---|---|
| Universitat Politècnica de València | OTHER |
| Instituto de Salud Carlos III | OTHER_GOV |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| - Patients with paroxysmal AF. | Patients with AF episodes that terminates spontaneously or with intervention in less than seven days with clinical indication of pulmonary vein ablation. |
| |
| - Patients with persistent AF. | Patients with AF episodes that fails to self-terminate within seven days or require pharmacologic or electrical cardioversion to restore sinus rhythm with clinical indication of pulmonary vein ablation.. |
| |
| - Patients with mitral stenosis. | - Patients with mitral stenosis and clinical indication for AF ablation undergoing percutaneous balloon mitral valvuloplasty (PBMV) with clinical indication of pulmonary vein ablation.. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pulmonary vein ablation | Procedure | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Freedom from atrial fibrillation off antiarrhythmic medications in patients with either paroxysmal, persistent AF or valvular stenosis AF. | 12 months post-first ablation procedure |
| Measure | Description | Time Frame |
|---|---|---|
| Freedom from atrial fibrillation on or off antiarrhythmic medication post-first ablation procedure and after redo procedures. | at 6 and 12 months | |
| Freedom from atrial fibrillation and other atrial arrhythmias post-first ablation procedure and after redo procedures. |
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Inclusion Criteria:
Exclusion Criteria:
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AF patients with different mechanisms of maintenance (i.e. paroxysmal, persistent, valvular) and clinical indication for AF ablation.
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| Name | Affiliation | Role |
|---|---|---|
| Felipe Atienza, MD | Red de Investigación Cardiovascular | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Felipe Atienza Fernandez | Madrid | 28007 | Spain |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25500229 | Background | Atienza F, Almendral J, Ormaetxe JM, Moya A, Martinez-Alday JD, Hernandez-Madrid A, Castellanos E, Arribas F, Arias MA, Tercedor L, Peinado R, Arcocha MF, Ortiz M, Martinez-Alzamora N, Arenal A, Fernandez-Aviles F, Jalife J; RADAR-AF Investigators. Comparison of radiofrequency catheter ablation of drivers and circumferential pulmonary vein isolation in atrial fibrillation: a noninferiority randomized multicenter RADAR-AF trial. J Am Coll Cardiol. 2014 Dec 16;64(23):2455-67. doi: 10.1016/j.jacc.2014.09.053. |
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| ID | Term |
|---|---|
| D001281 | Atrial Fibrillation |
| D008946 | Mitral Valve Stenosis |
| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
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| at 6 and 12 months |
| Incidence of peri-procedural complications | during ablation procedure and 12 months after |
| Procedure duration | 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. | 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. | During ablation procedure, and valvuloplasty if indicated |
| Atrial fibrosis determination using late gadolinium enhancement-MRI | At 6 and 12 months |
| Fluoroscopy time | During ablation procedure, and valvuloplasty if indicated, in minutes |
| D013568 |
| Pathological Conditions, Signs and Symptoms |
| D006349 | Heart Valve Diseases |