First Patients Enrolled in Atrial Fibrillation Trial
December 3, 2010 – The initial patients have been enrolled in a trial for treating atrial fibrillation (AF). The DEEP AF trial will evaluate the safety and efficacy of a dual epicardial/endocardial procedure, or hybrid procedure, using AtriCure’s minimally invasive surgical ablation platform. In addition, it will use Thermocool catheter ablation products from Biosense Webster.
The first procedure was performed in a hybrid room at Sentara Norfolk General Hospital in Norfolk, Va., by Jonathan Philpott, M.D., Ian Woollett, M.D., and John Onufer, M.D. Philpott, Woollett and Onufer are co-principal investigators of the trial and are collaborating with Robert Bernstein, M.D., and Philip Gentlesk, M.D.
The hybrid procedure, designed to treat patients with persistent and long-standing atrial fibrillation, combines the benefits of both minimally invasive surgical ablation and catheter ablation and mapping techniques. The feasibility trial will enroll 30 patients and is being conducted at six U.S. medical centers.
“We believe that this investigational hybrid procedure has the potential to represent an important advancement in the treatment of patients with persistent AF,” Onufer said. “These patients represent the largest segment of the AF population and currently have limited effective treatment alternatives. Our initial experience with this hybrid procedure suggests that it represents a highly promising AF treatment.”
“Our preliminary experience has been that the procedure is both safe and effective,” Philpott said. “The partnership that this hybrid procedure creates between the electrophysiologist and the cardiac surgeon provides patients with a comprehensive ablation and mapping procedure, leveraging the skills and technologies of each specialist.”
To date, the U.S. Food and Drug Administration (FDA) has not cleared any products for treating patients with persistent AF.
For more information: www.atricure.com