CARLSBAD, Calif., Jan. 28, 2019 — Acutus Medical today announced 12-month data from the UNCOVER-AF trial investigating the use of the AcQMap advanced cardiac imaging and mapping visualization system in persistent atrial fibrillation (AF) ablation procedures. Results presented at the 24th Annual AF Symposium in Boston show the use of AcQMap resulted in 72.5 percent single-procedure freedom from AF at 12 months. Rigorous post-ablation monitoring showed 89.6 percent of the single-procedure patients experienced zero episodes of AF.
Atrial fibrillation is the most common supraventricular cardiac arrhythmia, effecting more than 33 million people globally.1,2 AF can lead to increased risk of stroke and heart failure, contributing to an estimated 130,000 deaths annually in the United States.3 Cardiac ablation treatment can be effective in reducing AF burden and improving quality of life for patients. However, long-term freedom from AF is achieved in as few as 50 percent of patients who undergo an ablation procedure, often making repeat procedures necessary.4
"We have mapped arrhythmias with the same technology for decades without asking if there's a better way to locate ablation targets and deliver a more precise, patient-specific therapy," said principal investigator Dr. Atul Verma, Ontario, Canada. "The results of the UNCOVER-AF trial demonstrate that with better imaging, we can perform patient-centric ablations with great success, while dramatically improving patient quality of life. This advanced cardiac imaging system paints a complete, high-definition picture in real time and is an important step in advancing the standard of care for AF ablation procedures."
UNCOVER-AF is the first trial to investigate the use of AcQMap to guide ablation therapy in a prospective study of persistent atrial fibrillation. Using AcQMap and a variety of on-market ablation technologies, investigators treated a total of 127 patients with de novo, persistent AF at 13 sites in Europe and Canada using an iterative, adaptive therapeutic approach. In 98 percent of patients, sinus rhythm was achieved at the end of the procedure. Freedom from AF after one or two procedures occurred in 93 percent of patients and 82.4 percent of patients experienced zero AF episodes in the 12 months following. Cleared by the FDA in 2017, AcQMap is the only ultrasound and non-contact cardiac imaging system available for use. The AcQMap system received CE marking in 2016.
"Acutus Medical has an unwavering focus on developing technology that accelerates success and improves outcomes in electrophysiology procedures. A historical lack of innovation in cardiac mapping led to the unfortunate and common belief that repeat ablations are simply unavoidable; the UNCOVER-AF results suggest we can do better with AcQMap imaging and adaptive therapy," said Vince Burgess, CEO of Acutus Medical. "These early results have only scratched the surface of potential. Unprecedented clarity with AcQMap could help physicians improve AF ablation outcomes by providing tailored therapy options and reducing the need for repeat procedures. That's improvement that saves time, reduces financial burden and most importantly makes life better for patients."
AcQMap combines proprietary charge mapping and high-resolution ultrasound imaging to create animated, three-dimensional images in seconds that display precise anatomy and atrial arrhythmias. With AcQMap, physicians can create a full-chamber, 360-degree look at the atrium in real time for each individual patient, enabling truly customized treatment for every case using an iterative map, ablate, re-map, ablate strategy.
About Acutus Medical
Acutus Medical is a dynamic arrhythmia care company focused on developing distinct, innovative technologies that provide physicians and patients with improved results. At Acutus, we know that seeing is better than believing. Diagnosing and treating patients with atrial arrhythmias requires eliminating the unknown. Acutus' advanced cardiac imaging and mapping system provides real-time arrhythmia visualization displaying the heart's true activation pattern, turning the chaos of an atrial arrhythmia into a clear vision for electrophysiologists. Founded in 2011, Acutus is based in Carlsbad, California.
1 Staerk L, Sherer JA, Ko D, et al. Atrial Fibrillation. Circ Res 2017;120:1501-17. DOI: 10.1161/CIRCRESAHA.117.309732.
2 Chugh, S.S., Havmoeller, R., Narayanan, K. et al. Worldwide epidemiology of atrial fibrillation: a Global Burden of Disease 2010 Study. Circ Feb 25. 2014; 129: 837–847. DOI: 10.1161/CIRCULATIONAHA.113.005119.
3 Centers for Disease Control and Prevention. About multiple cause of death 1999–2011. CDC WONDER Online Database. 2014. http://wonder.cdc.gov/mcd-icd10.html.
4 Mujović N, Marinković M, Lenarczyk R, Tilz R, Potpara TS. Catheter Ablation of Atrial Fibrillation: An Overview for Clinicians. Adv Ther. 2017;34(8):1897-1917. DOI: 10.1007/s12325-017-0590-z.