AtriCure has announced that first patient was enrolled in the US stroke feasibility study designed to evaluate the AtriClip left atrial appendage (LAA) exclusion system for stroke reduction in atrial fibrillation patients.
Franciscan St. Francis Health, Indiana, cardiovascular and thoracic surgery chief Dr Marc Gerdisch performed the first procedure.
The single-arm stroke feasibility study has been 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.
The feasibility study will be conducted at seven centers in the US and approximately 30 patients are expected to be enrolled in the prospective study, which is being conducted under the US Food and Drug Administration’s (FDA) Investigational Device Exemption (IDE).
AtriCure, pending the completion of the stroke feasibility study, 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 added.
AtriClip LAA exclusion system has previous received the FDA approval for the occlusion of left atrial appendage, under direct visualization, in conjunction with other open cardiac surgical procedures.