US-based medical device company AtriCure has announced enrolment of the first patient in the stroke feasibility study evaluating its AtriClip left atrial appendage (LAA) exclusion system for stroke reduction in atrial fibrillation patients.
The first procedure, through a minimally invasive surgical approach, was performed by Franciscan St Francis Health, Indiana, cardiovascular and thoracic surgery chief Dr Marc Gerdisch.
The stroke feasibility study is a prospective, single-arm trial designed to evaluate the initial safety and efficacy of the AtriClip for stroke prevention in patients with non-valvular atrial fibrillation, in whom long-term oral anticoagulation therapy is medically contraindicated.
Approximately 30 patients will be enrolled in the study, which will be conducted at seven centres in the US. The multi-centre study is being conducted under the US Food and Drug Administration’s (FDA) investigational device exemption (IDE).
Pending completion of the stroke feasibility study, AtriCure would pursue an IDE pivotal trial to expand this study where the clinical data will be used to support a future indication for stroke prophylaxis in patients contraindicated to oral anticoagulation therapy.
AtriCure CEO Mike Carrel said that this study is key to fulfilling the company’s commitment to developing compelling Afib solutions that decrease the social and economic burden of atrial fibrillation.
"We are enthusiastic that our first patient has been enrolled and that we are moving forward with this landmark trial, as we strive to improve the lives of patients with Afib," Carrel said.
Previously, the FDA cleared the AtriClip LAA exclusion system for the occlusion of left atrial appendage, under direct visualisation, in conjunction with other open cardiac surgical procedures.