CAPLA trial: Catheter Ablation for persistent atrial fibrillation: A Multicentre randomised trial of Pulmonary vein antral isolation (PVAI) vs PVAI with posterior left atrial wall isolation (PWI).

1. name / Phrase: CAPLA trial: Catheter Ablation for persistent atrial fibrillation: A Multicentre randomised trial of Pulmonary vein isolation (PVI) vs PVI with post Left Atrial wall isolation (PWI). 2. Goal / Elements: Atrial fibrillation (AF) ablation also known as pulmonary vein isolation (PVI) has become standard practice and recommended for patients with symptomatic paroxysmal AF (PAF). However, the optimal ablation strategy for patients with persistent atrial fibrillation (PsAF) is not known. Current guidelines recommend use of PVI only in this patient population which we also know is ineffective. Recent evidence has shown that posterior wall isolation (PWI) in addition to PVI may offer benefit in patients with PsAF. Hence we have designed this randomised trial comparing PVI alone vs PVI + PWI and assess 12 month outcomes. 3. Materials: This trial incorporates standard practice for patients with PsAF. All patients will be seen at our arrhythmia clinic with written information provided about atrial fibrillation and the management options available as per routine care. If they are selected for intervention based on clinical and standard management guidelines, they will then be offered enrollment in our trial. If they choose to, addition written information will be provided at that point about the interventions. All trial patients will be followed up closely at 3, 6 and 12 months after intervention. 4. Procedures: Standard / Routine pulmonary vein isolation will be performed in all patients. The additional step in those randomised to the posterior wall isolation will involve a roof and inferior line that is also considered routine care in patients with persistent atrial fibrillation. The standard procedure involves minimally invasive procedure in which patient is taken to the cardiac catheter laboratory. Procedure performed under general anaesthesia. femoral venous access obtained through with catheters are advanced into the heart. The pulmonary veins in the left atrium are targeted with radio frequency ablation using special catheters that can deliver radiofrequency energy to the atrial tiuuse. At the end of the procedure, all sheaths and catheters removed from body. 5. Care provided by Cardiologist and Electrophysiologists who will be looking after the patients regardless of whether they are part of the trial. 6 & 7. Modes of delivery locations: Care and intervention will be provided directly. Location will be tertiary hospitals. 8. Intervention: Interventions will be performed once as part of the trial. Subsequent intervention will be based on patients’ clinical indication and the physician recommendation. Approximate duration of procedure in the PVI group is 2.5 hours. The PVI + PWI group is expected to be slightly longer at approximately 3 hours. 9 & 10. Tailoring or modification: During the ablation, the proceduralist will decide if any additional intervention is clinically necessary or recommended as part of patient care. Any intervention required for the benefit of the patient will be undertaken as needed.