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| Name | Class |
|---|---|
| Fundación Centro Nacional de Investigaciones Cardiovasculares Carlos III | OTHER |
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The purpose of this study is to assess the value of ablation of high frequency sources following circumferential pulmonary veins isolation in patients with paroxysmal and persistent atrial fibrillation.
Atrial fibrillation (AF) is the most common arrhythmia in clinical practice, accounts for one-third of arrhythmia hospitalizations and is associated with an increased risk of stroke, heart failure, and all-cause mortality. Moreover, there is an increasing AF prevalence due to aging of the population, a rising prevalence of chronic heart disease, and increased survival. Unfortunately, medications aimed at suppressing AF and maintaining sinus rhythm or at controlling ventricular rate are only marginally effective and may cause serious adverse effects. The limitations of pharmacologic treatment patterns have fuelled the development of new interventional strategies. Current techniques of AF ablation can achieve a 60-80% improvement in highly selected patients with medically refractory AF. However, the procedure is not without risk, is long-lasting and recurrence rates are still high. Moreover, the results in persistent AF patients are far from optimal, require the creation of extensive atrial lesions and repeated procedures. The main reason that explains the current situation is the incomplete understanding of mechanisms underlying AF maintenance despite many years of research and speculation. The incremental value of ablation of high frequency sources following circumferential PV isolation has not been assessed. There is no prospective data available as to the safety and benefit of such a combined approach in patients with paroxysmal and persistent AF. Such information would be very important in helping guide the future direction of ablative therapy for AF as well as helping to answer important questions about the role of high frequency sites in persistent AF treatment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Active Comparator | In patients with paroxysmal atrial fibrillation: Empirical pulmonary vein antrum circumferential isolation. In patients with persistent atrial fibrillation: Empirical circumferential PV antrum isolation w/out roof line. |
|
| 2 | Active Comparator | In patients with paroxysmal atrial fibrillation: High frequency sites ablation in the LA. In patients with persistent atrial fibrillation: A combined approach involving pulmonary vein antrum isolation w/out roof line and high frequency sites ablation |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Radiofrequency catheter ablation | Procedure |
|
| Measure | Description | Time Frame |
|---|---|---|
| Freedom from atrial fibrillation at 6 months post-first ablation procedure off antiarrhythmic medications. | Freedom from atrial fibrillation at 6 months post-first ablation procedure off antiarrhythmic medications in patients with either paroxysmal or persistent AF (primary analysis population) | 6 month post first-ablation procedure |
| Measure | Description | Time Frame |
|---|---|---|
| Freedom from atrial fibrillation on or off antiarrhythmic medications at 3, 6 and 12 months post-first ablation procedure. | 3, 6 and 12 month post-first ablation procedure | |
| Freedom from atrial fibrillation and other atrial arrhythmias at 3, 6 and 12 months post-first ablation procedure |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Felipe Atienza, MD | Hospital General Universitario Gregorio Marañon | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Juan Canalejo | A Coruña | A Coruña | 15006 | Spain | ||
| Hospital Vall d'Hebron |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25500229 | Derived | 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 |
| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
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| ID | Term |
|---|---|
| D017115 | Catheter Ablation |
| ID | Term |
|---|---|
| D000078703 | Radiofrequency Ablation |
| D000078702 | Radiofrequency Therapy |
| D013812 | Therapeutics |
| D055011 | Ablation Techniques |
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|
| 3, 6 and 12 month post-first ablation |
| Need of redo procedures after 6 months | after 6 month of ablation procedure |
| Incidence of peri-procedural complications including stroke, PV stenosis, cardiac perforation, esophageal injury, and death | During the procedure and follow-up |
| Procedure duration | During the procedure |
| Fluoroscopy time | During the procedure |
| Quality of life measurements (SF-36) at baseline, 3, 6 and 12 months post-first procedure | Baseline, 3, 6 and 12 month |
| Barcelona |
| Barcelona |
| 08035 |
| Spain |
| Hospital de Basurto | Bilbao | Bilbao | 48013 | Spain |
| Clínica San Sebastian | Bilbao | Bilbao | 48014 | Spain |
| Hospital General Universitario Gregorio Marañon | Madrid | Madrid | 28007 | Spain |
| Hospital Universitario Ramón y Cajal | Madrid | Madrid | 28034 | Spain |
| Hospital 12 de Octubre | Madrid | Madrid | 28041 | Spain |
| Hospital Universitario La Paz | Madrid | Madrid | 28046 | Spain |
| Grupo Hospital de Madrid | Madrid | Madrid | 28050 | Spain |
| Hospital Virgen de las Nieves | Granada | 18014 | Spain |
| Hospital Virgen de la Salud | Toledo | 45004 | Spain |
| D013568 |
| Pathological Conditions, Signs and Symptoms |
| D013514 |
| Surgical Procedures, Operative |