AtriCure, Inc. (Nasdaq: ATRC), a leading innovator in surgical treatment for atrial fibrillation (Afib) and left atrial appendage management, today announced the restart of the DEEP IDE trial (NCT02393885).
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 Dual Epicardial and Endocardial Procedure clinical trial (DEEP) trial is a prospective, multicenter, single arm, investigational device exempt (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 (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.
The global principal investigators for this trial are Dr. Kenneth Ellenbogen and Dr. Vigneshwar Kasirajan, from Virginia Commonwealth University, and Dr. Ali Khoynezhad, from Memorial Care Health & Vascular Institute at Long Beach, California.
“The DEEP trial brings electrophysiologists and cardiac surgeons together as a team in an effort to establish a safe and effective care pathway for patients presenting with persistent or long-standing persistent Afib. We are excited about the restart of enrollment in this important trial,” said Professor Mark La Meir, Professor of Cardiothoracic surgery at UZ Brussels who along with Professor de Asmundis treated the first patient upon restart.
“The DEEP trial reinforces AtriCure’s commitment to continue to expand the presence in minimally invasive treatment of persistent and long-standing persistent patients and to improve the lives of these difficult to treat patients,” said Michael Carrel, President and Chief Executive Officer of AtriCure. “We’ve worked very closely with the FDA and with our investigators to do everything we can to ensure a safe, effective and repeatable procedure.”