Strategy of Crossing Two Ablation Techniques (Cryoballoon and Radiofrequency) After the Recurrence of Paroxysmal AF and the Need for a New Procedure

Study Overview
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Brief Summary
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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.

Official Title
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X-TRA CLINICAL TRIAL (X-therapy for Redo AF Ablation). Strategy of Crossing Two Ablation Techniques (Cryoballoon and Radiofrequency) After the Recurrence of Paroxysmal AF and the Need for a New Procedure

Conditions
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Atrial Fibrillation

Intervention / Treatment
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* Procedure: Ablation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Paroxysmal FA (one that ends, spontaneously or not, within 7 days of its onset. GUIDELINES ESC FA 2020) Have undergone an initial AF ablation procedure using Cryoballoon or point-to-point focal RF within the three years prior to the initial visit. During the initial AF ablation procedure ONLY pulmonary vein isolation / ablation will have been performed Documented recurrence of AF lasting more than 30 seconds after the first ablation procedure. With the ability and willingness to sign the informed consent of the patient. With a minimum follow-up capacity of 12 months. Exclusion Criteria: Patients aged <18 years. Previous heart surgery. Moderate or severe mitral valve disease. Severe dilation of the left atrium, defined as a volume greater than 48 ml / m2 or a left atrial diameter greater than 50 mm in the parasternal long axis. Contraindication for anticoagulation. Pregnancy or pregnancy intention during the 12-month follow-up. Life expectancy less than 12 months. Unavailability for follow-up for 12 months. Simultaneous participation in another clinical trial

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 |
| --- | --- |
| Experimental: Cross-over of ablation technique<br>Cross-over of cardiac ablation procedures (cryotherapy and radiofrequency; radiofrequency and cryotherapy) | Procedure: Ablation<br>* Cryotherapy and radiofrequency<br>|
| No Intervention: Repetition of the same technique<br>Repeat the same procedure (cryotherapy and cryotherapy; radiofrequency and radiofrequency) | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 
| 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 |