CONVERGE POST-APPROVAL STUDY
Post-Approval Study Protocol For Hybrid Convergent Of Epicardial RF Ablation And Endocardial Ablation For The Treatment Of Symptomatic Long-standing Persistent AF
Duration of Study in the UK
4 years, 2 months, 30 days
The purpose of the research study is to learn more about the safety and effectiveness of the EPi-Sense®-AF Guided Coagulation System in a large group of subjects with symptomatic long-standing persistent atrial fibrillation (AF). The EPi-Sense®-AF Guided Coagulation System is approved by the FDA for treatment of symptomatic long-standing persistent atrial fibrillation (greater than 12 months duration).
Up to 325 subjects in the US, UK, and EU will be treated as part of the study. Treated subjects will be assessed for primary safety through 30-days post-procedure and for the primary effectiveness through 12-months post-procedure. Long-term effectiveness information will be obtained through 24- and 36-month assessments.
London - Harrow Research Ethics Committee
Date of REC Opinion
10 Feb 2023
Further Information Favourable Opinion