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| ID | Type | Description | Link |
|---|---|---|---|
| EudraCT: 2008-006095-30 |
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| Name | Class |
|---|---|
| Medtronic | INDUSTRY |
| Fundacio Clinic Barcelona | OTHER |
| Biosense Webster, Inc. | INDUSTRY |
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The purpose of this study is to compare the effectivity and safety of atrial fibrillation ablation, in comparison to antiarrhythmic drug therapy in patients with refractory, persistent atrial fibrillation.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Atrial Fibrillation Ablation | Experimental |
| |
| Drug therapy | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Atrial fibrillation ablation | Procedure | Atrial fibrillation ablation with radiofrequency, guided by 3D navigation map. Either 4mm or cooled tip-catheters will be used. It will include, at least, pulmonary veins isolation; all other radiofrequency lines, including roof and mitral isthmus line, and complex fractioned electrograms ablation will be performed according to each Hospital protocol. Radiofrequency lines block will be tested. |
| Measure | Description | Time Frame |
|---|---|---|
| Freedom from atrial arrhythmias, lasting more than 24 hours or requiring cardioversion. | 1-year follow-up |
| Measure | Description | Time Frame |
|---|---|---|
| Freedom from atrial arrhythmias (lasting more than 30 seconds) without antiarrhythmic drugs. | 1-year follow-up | |
| Decrease in frequency and duration of atrial fibrillation or atrial flutter recurrences. | 1-year follow-up |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Lluís Mont, MD | Hospital Clinic of Barcelona | Study Chair |
| Angel Arenal, MD | Hospital Gregorio Marañon | Study Director |
| Julian Villacastin, MD | Hospital San Carlos, Madrid | Study Director |
| Josep Brugada, prof Md. PHD | Hospital Clinic of Barcelona | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Clinic Universitari | Barcelona | Barcelona | 08036 | Spain | ||
| Hospital de Sant Pau |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24135832 | Derived | Mont L, Bisbal F, Hernandez-Madrid A, Perez-Castellano N, Vinolas X, Arenal A, Arribas F, Fernandez-Lozano I, Bodegas A, Cobos A, Matia R, Perez-Villacastin J, Guerra JM, Avila P, Lopez-Gil M, Castro V, Arana JI, Brugada J; SARA investigators. Catheter ablation vs. antiarrhythmic drug treatment of persistent atrial fibrillation: a multicentre, randomized, controlled trial (SARA study). Eur Heart J. 2014 Feb;35(8):501-7. doi: 10.1093/eurheartj/eht457. Epub 2013 Oct 17. |
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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 |
|---|---|
| D000889 | Anti-Arrhythmia Agents |
| ID | Term |
|---|---|
| D002317 | Cardiovascular Agents |
| D045506 | Therapeutic Uses |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
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| Antiarrhythmic drug | Drug | Usual drug therapy for atrial fibrillation. In patients with structural heart disease, amiodarone is recommended, while flecainide plus diltiazem or beta-blockers are encouraged in patients without structural heart diseases. |
|
| Decrease in atrial fibrillation/atrial flutter related hospital admissions | 1-year follow-up |
| Improve in quality of life measured with standard questionary for Atrial Fibrillation: AF-QoL. | 1-year follow-up |
| Change in need of cardioversions | From 3rd to 12th months |
| Need of atrio-ventricular node ablation | 1-year follow-up |
| Need of crossover to the other arm of the study (only when primary end point has been reached) | 1-year follow-up |
| Need of a new intervention or ablation during blanking period | Until 3rd month |
| Detection of asymptomatic episodes by Reveal XT | 1-year follow-up |
| Presence of any complications in the acute phase or during follow-up | 1-year follow-up |
| Barcelona |
| Barcelona |
| Spain |
| Hospital de Cruces | Bilbao | Bizkaia | Spain |
| Clínica Puerta de Hierro | Madrid | Madrid | Spain |
| Hospital 12 de Octubre | Madrid | Madrid | Spain |
| Hospital Clínico San Carlos | Madrid | Madrid | Spain |
| Hospital Gregorio Marañon | Madrid | Madrid | Spain |
| Hospital Ramón y Cajal | Madrid | Madrid | Spain |
| D013568 |
| Pathological Conditions, Signs and Symptoms |