CONVERGE-PAS

Official Title

Post-Approval Study Protocol For Hybrid Convergent Epicardial RF Ablation And Endocardial Ablation For The Treatment Of Symptomatic Long-standing Persistent AF

Study Purpose

The primary objective of CONVERGE PAS is to evaluate clinical outcomes (peri-procedural and long-term) in a cohort of patients treated during commercial use of the EPi-Sense® Guided Coagulation System or EPi-Sense ST™ Coagulation System to treat symptomatic longstanding persistent atrial fibrillation (AF) patients who are refractory or intolerant to at least one Class I and/or III AAD.

Diagnosis

1. Left atrium ≤ 6.0 cm assessed with Transthoracic Echocardiography [TTE] with parasternal 4 chamber view or equivalent imaging modality. 2. Refractory or intolerant to at least one AAD (class I and/or III); 3. Subject has symptomatic (e.g., palpitations, shortness of breath, fatigue) longstanding persistent atrial fibrillation as defined by the 2017 HRS/EHRA/ECAS/APHRS/SOLAECE Guidelines. Minimum AF documentation requirement for longstanding persistent AF: a) Physician’s note indicating at least 1 year of continuous AF; and b) A 24-hour Holter within 90 days of the ablation procedure showing continuous AF. The performance of a successful cardioversion (sinus rhythm >30 seconds) within 12 months of an ablation procedure with documented early recurrence of AF within 30 days should not alter the classification of AF as longstanding persistent.

Eligibility

1. Patients requiring concomitant or planned surgery such as valvular repair or replacement, coronary artery bypass graft (CABG) surgery and atrial septal defect closure;
2. Left ventricular ejection fraction < 35%;

Intervention

EPi-Sense® Guided Coagulation System and EPi-Sense ST™ Coagulation System