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AtriCure Enrolls First Patient in Randomized Multi-Center Trial Evaluating Post-Operative Afib
This study will evaluate the effects of excluding the LAA in cardiac surgery patients at high risk of developing post-operative Afib
Postoperative Afib occurs in up to 30% of patients undergoing cardiac surgery.(1) Research has shown that specific risk factors predict patients at greatest risk.(2) POAF is associated with increased complications, increased reoperations and longer hospital length of stay.(3) The ATLAS study will compare the clinical impact of patients at highest risk of developing POAF to two randomized treatment arms: surgical left atrial appendage (LAA) exclusion (using AtriClip LAA Exclusion Systems) and patients with POAF and no surgical LAA exclusion. In addition, the study will evaluate healthcare resource utilization between the two groups.
“This is a very important study that will help us evaluate how left atrial appendage management can improve care for cardiac surgery patients,” said Michael Carrel, President and Chief Executive Officer of AtriCure. “Studies have shown that the incidence of POAF in patients undergoing cardiac surgery remains high in spite of numerous attempts to drive this complication of surgery down. This study will help us determine if a better care path exists for these at-risk patients with the ultimate goal of improving patient care and decreasing healthcare costs.(1)”
This observational study will evaluate the thromboembolic and hemorrhagic events of subjects diagnosed with POAF (AtriClip vs. no AtriClip) through 365 days post index procedure. The study will enroll up to 2,000 patients at 20 sites who are scheduled for cardiac surgery with specific risk factors for developing new onset POAF as well as significant risk factors for bleeding on commonly prescribed medications to decrease the risk of Afib-related stroke.
“Clinical equipoise exists between effective LAA exclusion at the time
of cardiac surgery vs prophylactic anti-coagulation of POAF in patients
at elevated risk of major bleeding.” said Dr. Basel Ramlawi, Chairman
Heart and Vascular Center,
"It is an honor and privilege for our team at Pinnacle to be part of
this highly important trial and enroll the first patient,” said
Shen, J., Lall, S., Zheng, V., Buckley, P., Damiano, R., and
Schuessler, R. The persistent problem of new-onset postoperative
atrial fibrillation: A single-institution experience over two decades.
The Journal of Thoracic and Cardiovascular Surgery, 2011, 141 (2), 559-570.
- Steinberg, BA, et. al, Management of POAF and Subsequent Outcomes in Contemporary Patients Undergoing Cardiac Surgery: Insights from the CAPS-Care STS AF Registry. Clinical Cardiology, 2014 January; 37(1), doi:10.1002/clc.22230.
Chua, SK, et al, Clinical Utility of CHADS2 and CHA2DS2-VASc scoring
systems for predicting postoperative atrial fibrillation after cardiac
The Journal of Thoracic and Cardiovascular Surgery, 2013:146:919-26.
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
Valerie Storch-Willhaus, 612-605-3311
Director, Corporate Marketing and Communications
Andy Wade, 513-755-4564
Senior Vice President and Chief Financial Officer