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Low recruitment
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Randomized phase III clinical trial to compare the efficacy of the two most widely used ablation techniques (cryotherapy and radiofrequency) after recurrence of atrial fibrillation (AF) in patients requiring a new ablation procedure.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cross-over of ablation technique | Experimental | Cross-over of cardiac ablation procedures (cryotherapy and radiofrequency; radiofrequency and cryotherapy) |
|
| Repetition of the same technique | No Intervention | Repeat the same procedure (cryotherapy and cryotherapy; radiofrequency and radiofrequency) |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ablation | Procedure | Cryotherapy and radiofrequency |
|
| Measure | Description | Time Frame |
|---|---|---|
| Compare the effectiveness of the technique crossover strategy versus the repetition of the same technique for the isolation of the pulmonary veins during a second ablation procedure indicated by recurrence of AF | The rate of recurrent AF will be documented to check whether it is better to cross ablation techniques or not. This efficacy is defined as the absence of documented AF recurrence lasting more than 30 seconds, during a 12-month follow-up after the second ablation procedure. | 42 months |
| Measure | Description | Time Frame |
|---|---|---|
| To compare the efficacy of the AF re-ablation procedure based on the initial technique and the technique of the second procedure, during a 12-month follow-up after the second ablation procedure. | The patient's events during follow-up will be evaluated through follow-up visits and verification of his medical history and the rate of recurrent AF will be documented. | 42 months |
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Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Universitario Virgen de las Nieves Granada | Granada | Andalusia | Spain | |||
| Hospital Virgen de la Victoria |
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| Analyze potential predictors of efficacy of each of the techniques based on the anatomy of the left atrium and pulmonary veins. Evaluate the number of reconnected pulmonary veins through cardiac imaging procedures | Evaluate the anatomical location of reconnection in each patient referred for re-ablation, depending on the technique used in the first procedure. | 42 months |
| Málaga |
| Andalusia |
| Spain |
| Complejo hospitalario universitario de Albacete | Albacete | Castille-La Mancha | Spain |
| Hospital Virgen de la Salud | Toledo | Castille-La Mancha | Spain |
| Complejo Hospitalario Universitario de Santiago de Compostela | Santiago de Compostela | Galicia | Spain |
| Hospital General Universitario de Alicante | Alicante | Valencia | Spain |
| Hospital Clínico Valencia | Valencia | Valencia | Spain |
| Hospital 12 de Octubre | Madrid | Spain |
| Hospital Puerta de Hierro | Madrid | Spain |
| ID | Term |
|---|---|
| D001281 | Atrial Fibrillation |
| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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