High Radiofrequency Power for Faster and Safer Pulmonary Veins Isolation - a Pilot Observational Study.

Study Overview
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Brief Summary
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The POWER FAST I pilot study is a unicentric, observational, non-randomized controlled clinical study. In the control group pulmonary veins isolation was performded in consecutive patients with irrigated radiofrequency cateters without contact force-sensing capabilities and using conventional low-power and long-duration radiofrequency parameters (20-30 W, 30-60 s) under continuous intracardiac-echo image and esophageal temperature monitoring. The study group consist of consecutive patients distributed in three succesive subgroups. In the study group radiofrequency ablation was performed using a point-by-point technique with contact-force catheters with different high-power and short-duration parameters: Subgroup 50W: power 50 W, application duration ≤ 30 s, target lesion index: LSI ≥ 5 or Ablation Index ≥ 350 (posterior wall) or ≥400 (anterior wall). Subgroup 60W: power 60 W, application duration 7-10 s, contact force ≥5 g. Subgroup 70W: power 70 W, application duration 9 s, contact force ≥5 g. The safety endpoint was evaluated with systematic esophageal endoscopy performed <72 h after the index procedure. The efficacy endpoint was evaluated: during the ablation procedure: acute procedural efficacy, firts-pass isolation of ipsilateral pulmonary veins, total radiofrequency and procedural time, acute reconnections and dormant conduction, during the follow-up: any atrial tachycardias documented and longer than 30 s were considered recurrences.

Official Title
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Feasibility, Safety and Mid-term Efficacy of Pulmonary Vein Isolation by High-power Short-duration Radiofrequency Application: the POWER FAST Pilot Study.

Conditions
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Cardiac Arrhythmia, Atrial Fibrillation, Atrial Tachycardia, Esophagus Injury

Intervention / Treatment
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* Other: Conventional LSI/AI-guided pulmonary veins ablation.
* Other: High-power pulmonary veins ablation.
* Other: Esophageal temperature monitoring
* Diagnostic Test: Esophageal endoscopy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Consecutive and unselected patients with a class I-IIa indication for ablation of paroxysmal or persistent AF. Informed consent. Exclusion Criteria: Previous surgical or catheter-based PVI. Stroke or acute coronary syndrome <6 months before ablation. Terminal comorbidities. Frailty, or clinical instability. Absolute contraindication for oral anticoagulation.

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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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Conventional ablation (CONTROL GROUP)<br>Pulmonary veins ablation. Anterior aspect: power 30 W, catheter dragging (30 s per point). Posterior aspect: point-by-point ablation using 30 W/30 s applications. If esophageal temperature measured with two independent esophageal probes exceeded 49 ºC radiofrequency settings were modified to 20 W/ 60 s and the number of radiofrequency applications minimized in areas with esophageal temperature rise. Al procedures were performed with continuos intracardiac echo image and esophageal temperature monitoring. | Other: Conventional LSI/AI-guided pulmonary veins ablation.<br>* Conventional (low-power and long-duration) radiofrequency application.<br>Other: Esophageal temperature monitoring<br>* Two probes were simultaneously used: a deflectable one and a non-deflectable one.<br>Diagnostic Test: Esophageal endoscopy<br>* Esophageal endoscopy for acute detection of esophageal thermal lesions <72 hours after ablation.<br>|
| High-power and short-duration ablation<br>Pulmonary veins ablation. Subgroup 50W: power 50 W, application duration ≤ 30 s, target lesion index: LSI ≥ 5 or Ablation Index ≥ 350 (posterior wall) or ≥400 (anterior wall). Subgroup 60W: power 60 W, application duration 7-10 s, contact force ≥5 g. Subgroup 70W: power 70 W, application duration 9 s, contact force ≥5 g. Intracardiac echo was not used. Esophageal temperature probes were used only in 6 patients in the subgroup 50W. | Other: High-power pulmonary veins ablation.<br>* Experimental (high-power and short-duration) radiofrequency application.<br>Diagnostic Test: Esophageal endoscopy<br>* Esophageal endoscopy for acute detection of esophageal thermal lesions <72 hours after ablation.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical feasibility (systematic use of the high-power and short-duration technique) | Feasibility of the high-power and short-duration radiofrequency technique. | Intraprocedural. | 
| Incidence of complications | Incidence of esophageal thermal lesiones. | < 72 hours after ablation. | 
| Acute efficacy | Acute pulmonary veins isolation, first-pass isolation, acute reconnections and dormant conduction. | Intraprocedural | 
| 1-year efficacy | Recurrence of atrial arrhythmias >30 seconds | One year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total radiofrequency time | Total radiofrequency time needed for definitive isolation of all pulmonary veins | Intraprocedural | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Atrial fibrillation, Ablatión, High-power, Radiofrequency, Esophageal lesion