Chronic Atrial Fibrillation Clinical Trial
Official title:
Hybrid Convergent of Epicardial and Endocardial RF Ablation for the Treatment of Symptomatic Longstanding Persistent AF
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 long-standing persistent atrial fibrillation (AF) patients who are refractory or intolerant to at least one Class I and/or III AAD.
In accordance with FDA's Guidance on Balancing Premarket and Post Market Data Collection for Devices Subject to Premarket Approval AtriCure proposes to conduct a post-approval study following the Agency's PMA approval of the CONVERGE pivotal trial. Currently there are no FDA-approved treatment options available for patients diagnosed with drug refractory, long-standing persistent AF, which is known to increase the risk of stroke by five-fold. The CONVERGE trial was conducted to address the treatment need in patients with advanced forms of AF, using a hybrid epicardial plus endocardial ablation approach. The Hybrid Convergent procedure and the EPi-Sense device have evolved over the past decade and now has a robust history of clinical use in approximately 10,000 patients. The totality of evidence generated from the CONVERGE trial and published literature provides reasonable assurance of the safety and effectiveness of the Hybrid Convergent procedure for the treatment of longstanding-persistent AF, which AtriCure believes will facilitate evidence-based decision-making between physicians and patients in addressing this disease for which there are no treatment options. A post-approval study synopsis is proposed herein to bolster the results of the CONVERGE pre-market pivotal study. Specifically, the aim of this study is to: 1. Further confirm the effectiveness of the EPi-sense device in a larger sample size by narrowing confidence intervals. 2. Demonstrate the proposed standard of care patient guidelines and mitigations for inflammatory pericardial effusions further reduce the observed safety event rates. 3. Demonstrate that the CONVERGE pre-market pivotal study results are generalizable across operators with varying levels of experience. Collect and report on long term outcomes of the Hybrid Convergent procedure. ;
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