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PLAI-AF Trial: Hybrid Endo-epicardial Partial Left Atrial Isolation vs. Endocardial Ablation in Patients With Persistent Atrial Fibrillation

RecruitingNAAges 18 Years - 75 YearsAllHospital Clinic of Barcelona
NCT05723536 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

In patients with symptomatic atrial fibrillation (AF), current clinical guidelines recommend ablation for rhythm control. While percutaneous ablation has good results in patients with paroxysmal AF, it is not clear which is the best technique in patients with persistent or long-standing persistent AF. Our group performed the first randomized study of thoracoscopic epicardial ablation vs. endocardial catheter ablation (FAST Trial), which showed better results for epicardial ablation but with a higher rate of complications. Hybrid epicardial and endocardial ablation strategies have recently been described sequentially, showing better results in patients with persistent AF, but 40% of patients are still refractory to ablation. Our study aims to compare the conventional strategy (catheter ablation) with partial electrical isolation of the left atrium endo-epicardially (pulmonary veins, pos

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📋 Eligibility rules (as published)
Inclusion Criteria: 1. Patients between the ages of 18 and 75, both inclusive, at the time of the consent date. 2. Patients with persistent atrial fibrillation refractory to at least one antiarrhythmic drug (Class I or III). 3. Signature of written informed consent. Exclusion Criteria: 1. Continuous Persistent atrial fibrillation of more than 4 years. 2. Moderate to severe valvular heart disease. 3. Severe atrial dilatation (left appendage AP diameter \> 55 mm or \> 50ml/m2). 4. Patients requiring concomitant cardiac surgery or with previous cardiac surgery. 5. Left ventricular ejection fraction \<40%. 6. History of pericarditis. 7. Previous stroke. 8. Presence of active infection or sepsis, esophageal ulcer stricture and/or esophageal varices. 9. Patients with renal dysfunction defined as GFR less than or equal to 40 ml/min/m2. 10. Contraindication for chronic anticoagulation. 11. Patients who have undergone prior left atrial catheter ablation for atrial fibrillation or who are receiving treatment for ventricular arrhythmia. 12. Patients with severe chronic obstructive pulmonary disease considered GOLD III. 13. Patients with active neoproliferative disease or other concomitant disease where the medical team considers that ablation places the patient at unacceptable risk. 14. Pregnant, lactating women. 15. Patients who have previously presented allergic reactions to gadolinium. 16. Patients with claustrophobia that makes it impossible to perform nuclear magnetic resonance. 17. Persistent AF \< 3 months
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What it tests

  • Partial Left Atrial Isolation
  • Catheter Ablation
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Where

1 site
Hospital Clínic de Barcelona
Barcelona, Spain
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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