AtriCure, Inc. a leader in cardiac surgical ablation systems has announced that it has closed enrollment in its DEEP AF feasibility trial, believing a staged approach will be more favourable for investigators in its forthcoming pivotal trial.
DEEP AF was designed to evaluate the safety and efficacy of combining AtriCure’s minimally invasive products with catheter technologies to treat patients with persistent and long-standing persistent atrial fibrillation, or AF. The procedure, also known as hybrid ablation, combines epicardial and endocardial ablation and mapping as part of a single session procedure. To date, 24 of 30 patients have been enrolled in the trial.
“We reached the decision to close enrollment in this feasibility study because we accomplished our objective of gaining a better understanding of the procedure prior to proceeding to a pivotal trial”
At a recent meeting, study investigators reviewed the clinical results and discussed the logistics of performing the hybrid ablation procedure in a single session. As a result of the discussion, AtriCure determined that a staged approach, where the minimally invasive surgical ablation procedure is performed and the catheter optimization is scheduled separately, may be more applicable to a larger number of investigators as AtriCure plans for a pivotal trial and commercialization. Consequently, AtriCure decided to close enrollment in the DEEP AF trial.
“We reached the decision to close enrollment in this feasibility study because we accomplished our objective of gaining a better understanding of the procedure prior to proceeding to a pivotal trial,” said David J. Drachman, President and Chief Executive Officer. “This feasibility study has demonstrated that the single session procedure is highly encouraging. However, it can present scheduling and logistical challenges as we look to widespread adoption. As a result, we are in the process of reviewing staged procedure alternatives and we plan to discuss these options with the FDA in the near term.”
Seven patients in the DEEP AF trial have six month follow-up data, which was documented through 14-day continuous holter monitoring. None of the patients experienced episodes of AF or atrial flutter. One patient experienced episodes of atrial tachycardia. Antiarrhythmic drugs were discontinued prior to rhythm assessment in all 7 patients. Of the 24 patients treated, 7 experienced primary adverse events that were reported and independently adjudicated. None of the adverse events were attributed to the investigational device. At the suggestion of the study investigators, an independent physician adjudicator graded the adverse events as mild, moderate or severe. All of the events were categorized as mild or moderate, except for one event that was classified as severe. The severe event was a stroke that occurred 27 days post procedure and resulted in death on day 30. The cause of the stroke could not be determined, therefore it was attributed to the procedure.
Dr. Steven J. Hoff, Assistant Professor, Department of Cardiac Surgery, Vanderbilt University Medical Center, commented, “We are impressed with the results from this hybrid ablation procedure for the treatment of AF patients. In the DEEP AF trial, the acute procedure success and six month efficacy data, while limited, was very encouraging. The acute results demonstrated the confirmation of effective block in all attempted lesions. 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 AF patients.”
Dr. Paul J. Wang, a leading electrophysiologist and Professor of Medicine, Director of Stanford Arrhythmia Service, commented, “I am very encouraged by the ability of the hybrid surgical and catheter ablation approach to restore sinus rhythm in patients with persistent and long-standing persistent AF, even in the presence of significantly enlarged atria. We look forward to continuing the investigation of this promising procedure when the study is revised and restarted in the future.”
Source: AtriCure
published: November 18, 2011 in: Cardio, Clinical Studies/Trials