AtriCure Announces the First Patient Enrolled in International Afib Study

AtriCure Inc. has enrolled its first patient 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. Company executives said this will be the largest study of its kind to date, covering more than 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 CEO 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 Doll, a 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 studies^1,2, 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 in Germany.

The coordinating investigators for the CEASE AF trial are Doll and Hindricks.

AtriCure Inc. develops atrial fibrillation (Afib) solutions designed to produce superior outcomes that reduce the economic and social burden of atrial fibrillation. AtriCure’s Synergy Ablation System is the first and only surgical device approved for the treatment of persistent and longstanding persistent forms of Afib in patients undergoing certain open concomitant procedures, according to the Mason, Ohio-based company. AtriCure’s AtriClip left atrial appendage management (LAAM) exclusion device is the most widely sold device worldwide that’s indicated for the occlusion of the left atrial appendage. The company believes cardiothoracic surgeons are adopting its ablation and LAAM devices for the treatment of Afib and reduction of Afib related complications such as stroke. AtriCure recently acquired nContact, a leader in minimally invasive technology for epicardial ablation. nContact’s mission is to transform the underserved arrhythmia population through a multidisciplinary epicardial-endocardial ablation approach. Afib affects more than 33 million people worldwide.

References:

1. Pison, L., La Meir, M., van Opstal, J., Blaauw, Y., Maessen, J.G., Crijns, H.J. Hybrid thoracoscopic surgical and transvenous catheter ablation of atrial fibrillation. J Am Coll Cardiol, 2012, 60 (1), 54-61.
2. Muneretto C, Bisleri G, Bontempi L, Curnis A. Durable staged hybrid ablation with thoracoscopic and percutaneous approach for treatment of long-standing atrial fibrillation: A 30-month assessment with continuous monitoring. J Thorac Cardiovasc Surg. 2012 Dec;144(6):1460-5.