High Radiofrequency Power for Faster and Safer Pulmonary Vein Ablation Trial (POWER FAST III)

Study Overview
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Brief Summary
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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).

Detailed Description
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Multicenter 1:1 randomized study: Hospital Universitario La Paz, Madrid; Hospital Clínico Universitario San Carlos, Madrid; Hospital Clínico y Provincial de Barcelona, Barcelona; Complejo Hospitalario de Navarra, Pamplona; Hospital Clínico Universitario de Valladolid; Hospital Clínico Universitario de Albacete; Hospital Clínico Universitario de Alicante; Hospital Universitario Virgen de las Nieves, Granada; Hospital La Fe, Valencia; Hospital Clínico 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.

Official Title
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High-power Short-duration Radiofrequency Application for Faster and Safer Pulmonary Vein Ablation Trial (POWER FAST III Trial)

Conditions
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Atrial Fibrillation, Catheter Ablation

Intervention / Treatment
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* Other: High-power and short-duration radiofrequency ablatio (70 W / 9-10 s)
* Other: Low-power (25-40 W) radiofrequency ablation guided by lesion size index (LSI) and ablation index (AI) values
* Other: Esophageal endoscopy
* Diagnostic Test: Daily 30-seconds ECG


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Paroxysmal or persistent atrial fibrillation. Currently accepted class I or II indication for ablation according to practice guidelines: symptomatic arrhythmia, failure of at least 1 antiarrhythmic drug or patient's manifest preference of ablation instead of drugs. Age > 18 years. Acceptance of informed consent. Exclusion Criteria: Previous pulmonary veins ablation of any type. Permanent atrial fibrillation. Heart surgery <3 months before ablation. Coronary revascularization of any type <3 months before ablation. Myocardial infarction or acute coronary syndrome < 3 months before ablation. Stroke or transient cerebral ischaemic attack < 3 months before ablation. Left atrial thrombus. Contraindication for anticoagulation. Absolute indication of double antiplatelet drugs. Complex congenital heart disease, corrected or not. Any clinical situation absolutely precluding an interventional procedure.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Conventional ablation<br>Point-by-point catheter-based pulmonary veins isolation using convencional radiofrequency parameters. Anterior aspect of pulmonary veins: 40 W, temperature limit 45 ºC, irrigation 17-30 ml/min; objective LSI>=6 or Ablation index >=500. Posterior aspect of pulmonary veins: 20-40 W, temperature limit 45 ºC, irrigation 17-3 ml/min; objective LSI>=5 or Ablation index >=350. | Other: Low-power (25-40 W) radiofrequency ablation guided by lesion size index (LSI) and ablation index (AI) values<br>* Pulmonary veins electrical isolation: low-power ablation.<br>Other: Esophageal endoscopy<br>* Esophageal endoscopy to detect postablation esophageal thermal lesions.<br>Diagnostic Test: Daily 30-seconds ECG<br>* Transtelephonic daily 30-seconds single lead electrocardiogram<br>* Other names: Transtelephonic daily 30-seconds single lead electrocardiogram;|
| Experimental: High-power and short-duration ablation<br>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. | Other: High-power and short-duration radiofrequency ablatio (70 W / 9-10 s)<br>* Pulmonary veins electrical isolation: high-power and short-duration ablation<br>Other: Esophageal endoscopy<br>* Esophageal endoscopy to detect postablation esophageal thermal lesions.<br>Diagnostic Test: Daily 30-seconds ECG<br>* Transtelephonic daily 30-seconds single lead electrocardiogram<br>* Other names: Transtelephonic daily 30-seconds single lead electrocardiogram;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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: recurrene 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 |