AtriCure Announces the First Patient Enrolled in International Afib Study
The collaborative study is the first international prospective randomized multicenter study of its kind
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
“This is the first international prospective randomized multicenter
study of its kind in these type of patients,” said
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.
The coordinating investigators for the CEASE AF trial are Prof. Dr.
About AtriCure
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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. - 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.
Forward-Looking Statements
This press release contains “forward-looking statements” within the
meaning of the Private Securities Litigation Reform Act of 1995.
Forward-looking statements include statements that address activities,
events or developments that AtriCure expects, believes or anticipates
will or may occur in the future, such as earnings estimates (including
projections and guidance), other predictions of financial performance,
launches by AtriCure of new products and market acceptance of AtriCure’s
products. Forward-looking statements are based on AtriCure’s experience
and perception of current conditions, trends, expected future
developments and other factors it believes are appropriate under the
circumstances and are subject to numerous risks and uncertainties, many
of which are beyond AtriCure’s control. These risks and uncertainties
include the rate and degree of market acceptance of AtriCure’s products,
AtriCure’s ability to develop and market new and enhanced products,
AtriCure’s ability to retain and attract key employees, the timing of
and ability to obtain and maintain regulatory clearances and approvals
for its products, the timing of and ability to obtain reimbursement of
procedures utilizing AtriCure’s products, AtriCure’s ability to continue
to be in compliance with applicable U.S. federal and state and foreign
government laws and regulations, AtriCure’s ability to consummate
acquisitions or, if consummated, to successfully integrate acquired
businesses into AtriCure’s operations, AtriCure’s ability to recognize
the benefits of acquisitions, including potential synergies and cost
savings, failure of an acquisition or acquired company to achieve its
plans and objectives generally, risk that proposed or consummated
acquisitions may disrupt operations or pose difficulties in employee
retention or otherwise affect financial or operating results,
competition from existing and new products and procedures, including the
development of drug or catheter-based technologies, or AtriCure’s
ability to effectively react to other risks and uncertainties described
from time to time in AtriCure’s SEC filings, such as fluctuation of
quarterly financial results, fluctuations in exchange rates for future
sales denominated in foreign currency, which represent a majority of
AtriCure’s sales outside of the
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Source:
AtriCure, Inc.
Media Relations
Valerie Storch-Willhaus,
612-605-3311
Director, Corporate Marketing and Communications
vstorch-willhaus@atricure.com
or
Investor
Relations
Andy Wade, 513-755-4564
Senior Vice President and
Chief Financial Officer
awade@AtriCure.com
