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Clinical study of imaging, mapping system for AF ablation begun
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Acutus Medical announced that the first procedure of the UNDERCOVER-AF study to evaluate the safety, effectiveness and efficiency of a novel system to guide ablation in patients with persistent atrial fibrillation has been completed.
The study will evaluate the system (AcQMap High Resolution Imaging and Mapping System, Acutus Medical) in patients with persistent AF treated at electrophysiology centers in Canada and Europe, according to a press release issued by the company.
The system received a CE mark in May for use in Europe, but is not yet approved for use in the United States.
According to the release, the system offers real-time CT-quality images of anatomy and mapping of the electrical conduction of each heartbeat, which enables the operator to see electric sources throughout the chamber and identify which sites are contributing to the patient’s AF.
Once a site has been ablated, the system can remap the next heartbeat in seconds to confirm whether ablation was successful and to pinpoint where additional treatment might be needed, the company stated in the release.
“The AcQMap System ushers in a new standard of care allowing [electrophysiologists] ... to fully visualize all the electrical mechanisms combined with the functional mechanism of AF,” Andrew Grace, PhD, FRCP, FACC, consultant cardiologist at Papworth Hospital in Cambridge, England, who performed the first procedure in the study, said in the release. “Being able to truly see each heartbeat in real time, with CT-quality imaging and full-chamber electrical-conduction maps has the potential to more accurately inform treatment decisions and improve patient outcomes.”
Disclosure : Grace reports consulting for Acutus Medical, Bardy Diagnostics, Boston Scientific, Medtronic and Xention Ltd., and being a co-founder of Electus Medical.