Medical device firm AtriCure has recruited first patient in a randomized multi-center trial evaluating post-operative atrial fibrillation (Afib).
Under the ATLAS (AtriClip Left Atrial Appendage Exclusion Concomitant to Structural Heart Procedures) clinical study, the company will examine the use of AtriClip device to lower complications associated with post-operative Afib (POAF).
The study will target specific cardiac surgery patient populations at the highest risk of developing POAF.
The first patient has been enrolled at PinnacleHealth Hospitals in Harrisburg, Pennsylvania.
AtriCure president and CEO Michael Carrel said: "This is a very important study that will help us evaluate how left atrial appendage management can improve care for cardiac surgery patients.
"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."
The trial will compare the clinical impact of patients at highest risk of developing POAF to two randomized treatment arms.
The arms include patients with surgical left atrial appendage (LAA) exclusion (using AtriClip LAA exclusion systems), as well as patients with POAF and no surgical LAA exclusion.
Expected to enroll around 2,000 patients at 20 sites, the trail will assess the thromboembolic and hemorrhagic events of subjects diagnosed with POAF through one year post index procedure.
In addition, the trial will assess healthcare resource utilization between the two groups.
AtriCure’s Synergy ablation system is claimed to be the first and only surgical device approved to treat persistent and longstanding persistent forms of Afib in patients undergoing certain open concomitant procedures.