Acutus Medical, an electrophysiology company, has completed the first patient procedure in the Utilising Novel Dipole Density Capabilities to Objectively Visualise the Etiology of Rhythms in Atrial Fibrillation (UNCOVER-AF) clinical study.
This trial will analyse the incidence of device and procedure-related safety, effectiveness and efficiency using the AcQMap High Resolution Imaging and Mapping System to guide ablation in atrial fibrillation (AF) patients.
In May, the firm secured CE Mark approval for the AcQMap System and AcQMap Catheter.
Currently, patients are being enrolled in the UNCOVER-AF clinical study at electrophysiology (EP) centres throughout Europe and Canada.
The first procedure was completed at Papworth Hospital in Cambridge, the UK.
Dr. Andrew Grace of Papworth Hospital said: “The AcQMap System ushers in a new standard of care allowing EPs who until now, have never been able to fully visualise all the electrical mechanisms combined with the functional mechanism of AF.
“Being able to truly see each heart beat 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.”
AF is a complex, heterogeneous, patient-specific arrhythmia with limited treatment options that includes oral medications, electric shocks to convert heart rhythm and empiric ablation strategies. Outcomes, irrespective of treatment options, have been disappointing.
This system combines a real-time CT quality anatomy with an ability to map the electrical-conduction of each heartbeat to accurately visualise electric sources across the entire chamber, thereby enabling pinpointing of sites essential for maintaining AF.
After guided treatment, the next heartbeat can be remapped in seconds to confirm successful ablation and define additional treatment, if required.
This progressive treatment strategy of mapping, ablating and remapping to systematically break down the complexity of the AF frequently leads to spontaneous termination with conversion to sinus rhythm.
Acutus president and CEO Randy Werneth said: “The initiation of this study marks another major milestone for the company and furthers our mission to improve the lives of patients living with persistent AF.
“We believe the clinical outcomes from UNCOVER-AF will confirm what we set out to achieve with this system, to allow EPs to obtain real-time images of the heart chamber and identify the true source of the arrhythmia, thus leading to improved patient outcomes and improved quality of life.”
Early clinical results using the AcQMap System have shown precise left atrial reconstruction when compared with CT/MRI and dipole density mapping, thereby providing a higher resolution than voltage-based mapping.