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

Ablation and Biventricular Pacing Boosts Survival in Selected Atrial Fibrillation Patients in APAF-CRT Trial. #ESC #ESCcongress
News | Atrial Fibrillation | September 13, 2021
September 13, 2021 — Ablation plus cardiac resynchronization therapy (CRT) is superior to pharmacological rate contro
The Medtronic Linq II implantable cardiac monitor.

The Medtronic Linq II implantable cardiac monitor.

News | Atrial Fibrillation | September 08, 2021
September 8, 2021 — Continuous heart rhythm monitoring – with...
The Adagio Medical iCLAS cryoablation system is commercial in Europe and is also part of an ongoing FDA IDE trial in the U.S. #HRS21
News | Atrial Fibrillation | August 09, 2021
August 9, 2021 — Adagio Medical Inc., a provider of catheter ablation technologies for...
Rhythm Therapeutics gene, stem cell, therapy for atrial fibrillation.
News | Atrial Fibrillation | April 19, 2021
April 19, 2021 — National Heart, Lung, and Blood Institute (NHLBI) has awarded a grant for $462,689 to Rhythm Therape
Medtronic's DiamondTemp Ablation (DTA) system is FDA cleared to treat patients with recurrent, symptomatic paroxysmal atrial fibrillation (AF) and who have been unresponsive to drug therapy. The DiamondTemp system is the first FDA-approved, temperature-controlled, irrigated radiofrequency (RF) ablation system with diamonds currently available to deliver ablations.

Medtronic's DiamondTemp Ablation (DTA) system is FDA cleared to treat patients with recurrent, symptomatic paroxysmal atrial fibrillation (AF) and who have been unresponsive to drug therapy. The DiamondTemp system is the first FDA-approved, temperature-controlled, irrigated radiofrequency (RF) ablation system with diamonds currently available to deliver ablations.

News | Atrial Fibrillation | January 29, 2021
January 29, 2021 — The U.S.
Patients with atrial fibrillation are at far greater risk of a catastrophic COVID outcomes, so steps should be taken to reduce AFib risks in addition to precautions against COVID like making, hand washing and social distancing. Images include an electromap from an AF ablation procedure and a COVID-19 from the CDC. 

Patients with atrial fibrillation are at far greater risk of a catastrophic COVID outcomes, so steps should be taken to reduce AFib risks in addition to precautions against COVID like making, hand washing and social distancing. Images include an electromap from an AF ablation procedure and a COVID-19 from the CDC. 

Feature | Atrial Fibrillation | January 27, 2021 | By John D. Day, M.D., T. Jared Bunch, M.D., and Matthew D. LaPlante
In our most challenging and distressing days, it is nice to think about a post-COVID-19 world. 
ECG with paroxysm correct form of atrial flutter. Getty Images

ECG with paroxysm correct form of atrial flutter. Getty Images

News | Atrial Fibrillation | December 23, 2020
December 23, 2020 — The American College of Cardiology (ACC) and the American Heart Association (AHA) has made two up