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Antecedents: electrical isolation of pulmonary veins is the standard treatment for patients with atrial fibrillation. However, its efficacy is lower in persistent and chronic forms of this arrhythmia compared to paroxysmal atrial fibrillation. Many complementary techniques have been proposed, that added to pulmonary veins isolation, may reduce the recurrence rate of atrial fibrillation. However, none of them has obtained consistent results. Linear ablation aims to parcellate and modify the left atrial substrate responsible for atrial fibrillation maintenance. Previous studies have offered contradictory results using linear ablation.
Methods: SUPAFER is a multicenter, 1:1 randomized clinical trial that compares the efficacy of pulmonary veins isolation alone vs pulmonary vein isolation plus an specific protocol of left atrial linear ablation. Contrary to previous studies, the specific SUPAFER linear ablation is systematic, homogeneous and target atrial areas that have not been systematically ablated in previous trials. The trial aims at demonstrating the superiority of the combined ablative approach during 1-year follow-up. Daily transtelephonic ECG samples a 30 days continuous ECG monitoring are used to maximize de detection of recurrences, even asymptomatic.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pulmonary veins isolation plus linear left atrial ablation. | Experimental |
| |
| Pumonary veins isolation only. | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Radiofrequency ablation of heart atrial tissue. | Other | Ablation with radiofrequency, advances techniques: contact force-guided, improved tissue temperature sensors, automark algorithms. |
| Measure | Description | Time Frame |
|---|---|---|
| Recurrences of sustained >30 secons atrial arrhythmias measured by daily ECG samples (Kardia Alivecor) and 30 days continuous Holter. | Atrial fibrillation, atrial tachycardia (atrial flutter). | through study completion, 1 year follow-up |
| Measure | Description | Time Frame |
|---|---|---|
| Acute intraprocedure efficacy. | Rate of: AF termination to sinus rhythm, organization to atrial tachycardia and non inducibility of AF or atrial tachycardia. | during the ablation procedure and up to 2 months blanking perior |
| Complications. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| José Luis Merino Llorens, MD, PhD | Contact | +34 912071301 | 441301 | lapaz@arritmias.net |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| La Paz University Hospital - IdiPaz | Recruiting | Madrid | Spain |
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1:1 randomization
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Complications associated to the ablation procedure.
| through study completion, 1year follow-up |