AtriCure has completed patient enrolment in its DEEP AF feasibility trial, designed to assess the safety and efficacy of integrating the company's minimally invasive products in the treatment of persistent and long-standing atrial fibrillation.
The hybrid ablation procedure combines epicardial and endocardial ablation and mapping as part of a single session procedure.
Of the 24 patients treated in the DEEP AF trial, none of the patients reported episodes of atrial fibrillation or atrial flutter, but seven experienced primary adverse events.
Vanderbilt University Medical Center Department of Cardiac Surgery assistant professor Steven Hoff said the DEEP AF trial demonstrated the success and efficacy data of the acute procedure.
''From our growing experience, we believe that this hybrid ablation procedure is highly impressive given this difficult to treat group of persistent and long-standing persistent atrial fibrillation patients," Hoff said.
AtriCure president and CEO David Drachman said the single session procedure can present scheduling and logistical challenges, and the company is in the process of reviewing staged procedure alternatives as a result.