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Multicenter 1:1 randomized study. Two atrial fibrillation ablation strategies are compared: 1) conventional ablation using point-by-point radiofrequency applications with power 40 W guided by LSI > 6 or AI > 500 on the anterior aspect of pulmonary veins and power 25 W guided by LSI >5 or AI >350 on the posterior wall near the esophagus; 2) point-by-point RF applications with power set at 70 W and duration 9-10 s. The main objective of the trial is the incidence of esophageal lesions evaluated with systematic endoscopy and clinical efficacy evaluated with daily ECG transtelephonic transmissions during 1-year follow-up. Secondary objectives include total RF time and parameters of acute PV isolation efficacy (first-pass isolation, acute reconnections and dormant conduction).
Multicenter 1:1 randomized study: Hospital Universitario La Paz, Madrid; Hospital ClÃnico Universitario San Carlos, Madrid; Hospital ClÃnico y Provincial de Barcelona, Barcelona; Complejo Hospitalario de Navarra, Pamplona; Hospital ClÃnico Universitario de Valladolid; Hospital ClÃnico Universitario de Albacete; Hospital ClÃnico Universitario de Alicante; Hospital Universitario Virgen de las Nieves, Granada; Hospital La Fe, Valencia; Hospital ClÃnico de Valencia; Hospital Universitario Juan Ramón Jiménez, Huelva; Hospital de la Ribera, Alzira, Valencia. España. Spain.
Two atrial fibrillation ablation strategies are compared: 1) conventional ablation using point-by-point radiofrequency applications with power 40 W guided by LSI > 6 or AI > 500 on the anterior aspect of pulmonary veins and power 25-40 W guided by LSI >5 or AI >350 on the posterior wall near the esophagus; 2) point-by-point RF applications with power set at 70 W and duration 9-10 s.
The main objective of the trial is the incidence of esophageal lesions evaluated with systematic endoscopy and clinical efficacy evaluated with daily ECG transtelephonic transmissions during 1-year follow-up. Secondary objectives include total RF time and parameters of acute PV isolation efficacy (first-pass isolation, acute reconnections and dormant conduction).
Subestudy: asymptomatic cerebral lesions detected by 1,5 T MRI <72 h after ablation. Not all centers participate in the subestydy. However, if the center participates, all patients in both ablation groups will be included in the subestudy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Conventional ablation | Active Comparator | Point-by-point catheter-based pulmonary veins isolation using convencional radiofrequency parameters.
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| High-power and short-duration ablation | Experimental | Point-by-point catheter-based pulmonary veins isolation using high-power and short duration radiofrequency: 70 W, duration per application 9-10 s (initial ramp 2-3 s according to the technical characterictics of radiofrequency sources), temperature limit 45 ºC, irrigation 17 ml/min, contac-force > 5 g. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| High-power and short-duration radiofrequency ablatio (70 W / 9-10 s) | Other | Pulmonary veins electrical isolation: high-power and short-duration ablation |
|
| Measure | Description | Time Frame |
|---|---|---|
| Safety: incidence of esophageal thermal lesions | Incidence of thermal esophageal lesions evaluated by endoscopy | 24 hours after ablation (permissible up to 72 hours after ablation) |
| Efficacy: recurrence of atrial arrhythmias | Recurrences of any atrial arrhythmias >30 seconds during 1-year follow-up evaluated by daily transtelephonic ECG transmissions (at least 1 ECG/day and additional transmissions whenever the patient perceives arrhythmia-related symptoms). | 1 year |
| Total radiofrequency time | Total radiofrequency time required for complete pulmonary veins isolation (included acute intraprocedural reconnections and dormant conduction). | during ablation procedure |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| José L Merino, PhD | Hospital Universitario La Paz, Madrid, España. | Principal Investigator |
| Sergio C Castrejón-Castrejón, PhD | Hospital Universitario La Paz, Madrid, España. | Study Chair |
| Carlos Escobar Cervantes, PhD | Hospital Universitario La Paz, Madrid, España. | Study Chair |
| Consuelo Froilán Torres, MD | Hospital Universitario La Paz, Madrid, España. | Study Chair |
| Andrés Fernández Prieto, MD | Hospital Universitario La Paz, Madrid, España. | Study Chair |
| Marcel MartÃnez Cossiani, MD | Hospital Universitario La Paz, Madrid, España. | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital La Paz, Department of Cardiology | Madrid | Spain |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39708035 | Derived | Castrejon-Castrejon S, Martinez Cossiani M, Basterra Sola N, Romero Roldan JD, Ibanez Criado JL, Osca J, Roca-Luque I, Moya A, Quesada A, Hidalgo Olivares VM, Perez Castellano N, Fernandez-Gomez JM, Macias-Ruiz R, Villanueva BB, Gonzalo Bada N, Froilan Torres C, Sanz Verdejo B, Sanchez Somonte P, Escobar Cervantes C, Moreno R, Merino JL; POWER FAST III Trial Investigators. High-Power Short-Duration Radiofrequency Application for Faster and Safer Pulmonary Vein Isolation: The POWER-FAST III Trial. JACC Clin Electrophysiol. 2025 Feb;11(2):350-361. doi: 10.1016/j.jacep.2024.10.009. Epub 2024 Dec 18. |
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| Low-power (25-40 W) radiofrequency ablation guided by lesion size index (LSI) and ablation index (AI) values | Other | Pulmonary veins electrical isolation: low-power ablation. |
|
| Esophageal endoscopy | Other | Esophageal endoscopy to detect postablation esophageal thermal lesions. |
|
| Daily 30-seconds ECG | Diagnostic Test | Transtelephonic daily 30-seconds single lead electrocardiogram |
|
|
| 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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| ID | Term |
|---|---|
| D000081982 | Laser Speckle Contrast Imaging |
| D004562 | Electrocardiography |
| ID | Term |
|---|---|
| D061848 | Optical Imaging |
| D003952 | Diagnostic Imaging |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D008919 | Investigative Techniques |
| D006334 | Heart Function Tests |
| D003935 | Diagnostic Techniques, Cardiovascular |
| D004568 | Electrodiagnosis |
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