AtriCure enrolls first patient in DEEP IDE trial restart
AtriCure announced the restart of the Dual Epicardial and Endocardial Procedure, or DEEP, clinical trial. Following approval by the FDA to restart the trial and enroll an additional 40 subjects, which was granted in December 2018, the first patient was treated by a team led by Professor Mark La Meir and Professor Carlo de Asmundis at Universitair Ziekenhuis Brussels, Belgium. "The DEEP trial is a prospective, multicenter, single arm, investigational device exempt, or IDE, study to evaluate the safety and efficacy of the DEEP procedure in treating persistent and long-standing persistent atrial fibrillation. The DEEP procedure utilizes the specialized skills of both the cardiac surgeon and electrophysiologist, or EP, for more severe cases of Afib, which have historically been the most difficult patients to treat. Up to 220 patients will be enrolled at up to 30 hospitals. Currently, 48 patients have been treated in the trial."