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

Launched by HOSPITAL CLINIC OF BARCELONA · Feb 2, 2023

Keywords

ClinConnect Summary

The PLAI-AF Trial is a study comparing two different treatment methods for patients with persistent atrial fibrillation (AF), a condition where the heart beats irregularly and can cause symptoms like palpitations and fatigue. The trial aims to see if a new approach called hybrid endo-epicardial partial left atrial isolation is more effective than the traditional catheter ablation technique. Both treatments aim to improve heart rhythm and reduce symptoms, but this study will help determine which method works better for patients who haven’t responded well to other treatments.

To participate, individuals must be between 18 and 75 years old and have persistent atrial fibrillation that hasn't improved with at least one medication. Before the procedure, participants will undergo tests to evaluate their heart function and structure. During the treatment, a device will monitor their heart rhythm, and follow-up tests will be done at three and six months after the procedure to assess the results. This trial is important because it could lead to better treatment options for people struggling with persistent AF, helping them achieve a more stable heart rhythm and improved quality of life.

Gender

ALL

Eligibility criteria

• 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. 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.