Atrial Fibrillation (Afib) specialist AtriCure, Inc., has announced the FDA’s approval to begin enrollment in a new 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 Afib.
The association between Afib and stroke risk is well established, studies having suggested that patients with Afib have a 500% increased risk of stroke compared with the general public. Add to that clinical findings that Afib related strokes are associated with higher morbidity and mortality than non-Afib related strokes.
The LAA is quite the buzz-phrase at the moment, especially with the news that Boston Scientific’s Watchman LAA occlusion device is shortly to be reviewed by the FDA’s circulatory devices panel. As a reminder, the LAA is a muscular pouch attached to the heart, and has been found to be the source of approximately 90% of thrombi in Afib patients evaluated after a confirmed stroke. By closing it, using mechanical means, it is expected that risk of thrombus formation and embolus generation during bouts of Afib, will be minimised with an associated reduction in incidence of stroke in this at-risk group.
Following earlier granting of a 510(k) marketing clearance, AtriCure’s AtriClip LAA Exclusion System is already indicated for the occlusion of the left atrial appendage, under direct visualization, in conjunction with other open cardiac surgical procedures. That clearance, which dates back to 2010, was based upon the successful results of the EXCLUDE trial in which complete and permanent exclusion of the LAA was confirmed in 98.4% of patients by a three month post procedure CT scan with zero complications or adverse events.
The newly rubber-stamped feasibility study will enroll Afib patients at seven medical centers 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 due to excessive risk of bleeding, estimated to be up to 40% of patients.
During the feasibility study, surgeons will place the AtriClip device directly onto the base of the LAA while the heart is still beating, using a minimally invasive approach. Complete exclusion of the LAA will be confirmed during the procedure using echo graphic imaging. Three months following the procedure, a computerized tomography (CT) scan will be performed to re-confirm complete and permanent LAA exclusion on all patients.
“Managing high risk Afib patients requires balancing the risk of stroke against the risk of major bleeding,” said Dr. 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 Afib patients that currently have very limited options. This will have a favorable impact on patients and the healthcare system overall.”
“The Stroke Feasibility IDE study is significant because it is the first of its kind to focus entirely on a group of untreated and undertreated Afib patients that may benefit the most from total and permanent exclusion of their left atrial appendage,” said Michael Carrel, President and Chief Executive Officer 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 Afib epidemic.”
Source: AtriCure, Inc.