AtriCure, a leading innovator in treatments for atrial fibrillation (Afib) and left atrial appendage management, today announced the first patient has been enrolled in the CEASE (Combined Endoscopic Epicardial and Percutaneous) AF clinical study.
The CEASE AF study will compare the results of a combined epicardial surgical plus endocardial catheter technique versus a standard endocardial catheter ablation technique for safety, efficacy and quality of life for patients with persistent or long-standing persistent Afib. In addition, the effects on economic measures of the two treatment strategies will be evaluated.
This will be the largest study of its kind to date, covering over 200 patients, comparing interventional ablation strategies in the setting of patients presenting with persistent AF with enlarged left atrium (> 4 cm patients) and longstanding persistent AF, which reflects a difficult to treat patient-subgroup.
"This is another significant milestone for AtriCure as we continue our advancements in the fight against Afib," said Michael Carrel, President and Chief Executive Officer of AtriCure "This important study focuses on a new standard of care for difficult to treat patients."
The study is intended to increase the level of evidence for a combined surgical plus catheter ablation approach as a therapy for the stand-alone treatment Afib. Increasing levels of evidence will also serve to support market access efforts in certain geographies, where direct clinical evidence is often required for purposes of attaining reimbursement. The first procedure was performed at the Sana Heart Center Stuttgart, Germany by Prof. Dr. Kai-Nicolas Doll, M.D.
"This is the first international prospective randomized multicenter study of its kind in these type of patients," said Nicolas Doll, MD, and Professor at Sana Heart Center in Stuttgart, Germany. "Until the CEASE AF study, studies were mostly single site."
This study hopes to prove that a hybrid approach that combines epicardial surgical ablation with percutaneous catheter ablation in a two-stage fashion, will provide superior clinical effectiveness through a period of 36 months, when compared with repeated endocardial catheter ablation in patients with the most severe forms of AF. This hypothesis is supported by recent studies1,2, indicating that hybrid ablation has higher success rates without the need for further interventions.
"The team approach which involves electrophysiologists and surgeons should have the potential to evolve into an effective treatment strategy for difficult to treat AF patients." According to Prof. Dr. Gerhard Hindricks, University of Leipzig Heart Center, Germany.
The coordinating investigators for the CEASE AF trial are Prof. Dr. Kai-Nicolas Doll, Sana Heart Center Stuttgart, Germany, and Prof. Dr. Gerhard Hindricks, University of Leipzig Heart Center, Germany.