The study will evaluate the use of the AtriClip left atrial appendage exclusion system to prevent stroke in patients with atrial fibrillation as alternative to anti-coagulation therapy.
Atricure has announced the Food and Drug Administration’s (FDA) approval to begin enrolment in a clinical study of Atricure’s AtriClip left atrial appendage exclusion system. The study will evaluate the use of the AtriClip device to prevent stroke in patients with atrial fibrillation.
The feasibility study will enrol atrial fibrillation patients at seven medical centres across the USA. The study will focus on patients with risk factors that place them at significant risk of stroke as well as substantial bleeding risks that contraindicate them for anticoagulation therapy.
Since the left atrial appendage has been found to be the source of approximately 90% of thrombi in atrial fibrillation patients evaluated after a confirmed stroke, this study will focus on complete and permanent mechanical closure of the left atrial appendage.
During the feasibility study, patients will undergo a minimally invasive surgical procedure. Utilising small incisions in the chest wall surgeons will place the AtriClip device directly onto the base of the left atrial appendage while the heart is still beating. Complete exclusion of the left atrial appendage is confirmed during the procedure using echo graphic imaging. Three months following the procedure, a computerised tomography (CT) scan will be performed to re-confirm complete and permanent left atrial appendage exclusion on all patients.
The AtriClip device is indicated for the occlusion of the left atrial appendage, under direct visualisation, in conjunction with other open cardiac surgical procedures. AtriCure received FDA 510(k) clearance for the AtriClip device in June 2010 based upon the successful results of the EXCLUDE trial. In this study, complete and permanent exclusion of the left atrial appendage was confirmed in 98.4% of patients by a three month post procedure CT scan with zero complications or adverse events.
“Managing high risk atrial fibrillation patients requires balancing the risk of stroke against the risk of major bleeding,” said Basel Ramlawi, a cardiothoracic surgeon at Houston Methodist DeBakey Heart Center and the principal investigator in the study. “This study is a major step toward developing the clinical evidence necessary to establish a viable, safe and attractive alternative to life-long anticoagulation in atrial fibrillation patients that currently have very limited options. This will have a favourable impact on patients and the healthcare system overall.”
“The stroke feasibility investigational device exemption study is significant because it is the first of its kind to focus entirely on a group of untreated and undertreated atrial fibrillation patients that may benefit the most from total and permanent exclusion of their left atrial appendage,” said Michael Carrel, president and CEO of Atricure. “This study is one of three FDA trials that Atricure is currently running as part of our strategy to be the leader in developing proven and effective solutions for the worldwide atrial fibrillation epidemic.”