“We are encouraged by the rate at which we were able to enroll this study and the outcomes thus far,” said Randy Werneth, President and Chief Executive Officer of Acutus.
Acutus Medical®, a company committed to transforming the lives of millions of patients with complex arrhythmias, today announced that enrollment has been completed in its pivotal Utilizing Novel Dipole Density Capabilities to Objectively Visualize the Etiology of Rhythms in Atrial Fibrillation (UNCOVER AF™) study evaluating the AcQMap® High Resolution Imaging and Mapping System in patients with persistent atrial fibrillation (AF) in Europe and Canada.
The UNCOVER AF clinical study is a prospective, multi-center, multi-national study designed to provide clinical evidence regarding the use of the AcQMap® System in the treatment of persistent AF. The trial is being conducted at 13 sites throughout Europe and Canada and has successfully completed enrollment of 129 patients.
“We are encouraged by the rate at which we were able to enroll this study and the outcomes thus far,” said Randy Werneth, President and Chief Executive Officer of Acutus. “We believe strongly in AcQMap’s ability to address critical unmet needs in mapping AF. AcQMap enables patient specific diagnosis, treatment guidance and confirmation of the delivered treatment that is intended to greatly benefit millions of patients who, until now, face a 50/50 chance of a successful outcome after an initial ablation procedure.”
Acutus received CE Mark approval for AcQMap in May 2016 and is currently pursuing U.S. FDA clearance for the system.