News | Structural Heart | February 18, 2016

AtriCure Enrolls First Patient in ATLAS Study

Randomized multi-center trial will evaluate the effects of excluding the left atrial appendage in cardiac surgery patients at high risk of developing post-operative atrial fibrillation

AtriCure, AtriClip, ATLAS study, first patient enrolled, POAF, post-operative atrial fibrillation

February 18, 2016 — AtriCure Inc. announced that the first patient was enrolled and treated at PinnacleHealth Hospitals in Harrisburg, Pa., in the ATLAS clinical study. This observational study explores the use of the AtriClip device to decrease complications associated with post-operative atrial fibrillation (POAF) by targeting specific cardiac surgery patient populations at the highest risk of developing POAF.

Postoperative Afib occurs in up to 30 percent of patients undergoing cardiac surgery. Research has shown that specific risk factors predict patients at greatest risk. POAF is associated with increased complications, increased reoperations and longer hospital length of stay. 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 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 versus prophylactic anti-coagulation of POAF in patients at elevated risk of major bleeding.” said Basel Ramlawi, M.D., chairman of the Heart and Vascular Center, Valley Health System/Winchester Medical Center, Winchester, Va. “The ATLAS trial has the potential to directly impact clinical practice for hundreds of thousands of cardiac surgical patients by answering this question.”

"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 Mubashir Mumtaz, M.D., FACS, FACC, chief of cardiovascular and thoracic surgery at PinnacleHealth Hospitals, who performed the first procedure in the study. “It demonstrates our partnership and commitment in understanding the importance of left atrial appendage management in cardiac surgery patients.”

For more information: www.atricure.com


Related Content

News | Atrial Fibrillation

April 25, 2025 – Medtronic plc, a global leader in healthcare technology, recently received U.S. Food and Drug ...

Home April 29, 2025
Home
News | Atrial Fibrillation

April 27, 2025 – The Heart Rhythm Society (HRS) has announced the findings of new studies demonstrating the safety and ...

Home April 28, 2025
Home
News | Atrial Fibrillation

April 24, 2025 – The Heart Rhythm Society (HRS) has unveiled new research that underscores the critical role of ...

Home April 25, 2025
Home
News | Atrial Fibrillation

April 23, 2025 – The Heart Rhythm Society (HRS) has released a framework outlining criteria for establishing an Atrial ...

Home April 23, 2025
Home
News | Atrial Fibrillation

April 7, 2025 — CardioVia, a medical device company specializing in advanced cardiac care solutions, has received U.S ...

Home April 08, 2025
Home
News | Atrial Fibrillation

March 29, 2025 — Anthos Therapeutics, Inc., presented two new analyses from its AZALEA-TIMI 71 study at the American ...

Home March 31, 2025
Home
News | Atrial Fibrillation

Broward Health recently announced it is now offering the Farapulse Pulsed Field Ablation System to treat atrial ...

Home March 12, 2025
Home
News | Atrial Fibrillation

March 1, 202 — One in three people worldwide will develop a potentially life-threatening heart rhythm disorder in their ...

Home March 03, 2025
Home
News | Atrial Fibrillation

Feb. 14, 2025 — Volta Medical, a health technology company developing artificial intelligence (AI) solutions to assist ...

Home February 14, 2025
Home
News | Atrial Fibrillation

Feb. 12, 2025 — On Feb. 11, 2025, at HonorHealth Research Institute, Rahul Doshi, M.D., cardiac electrophysiologist ...

Home February 12, 2025
Home
Subscribe Now