CathVision has announced the first patient enrolments in the PVISION multicentre clinical study, investigating the automated assessment of pulmonary vein isolation (PVI) using the company’s artificial intelligence (AI) algorithm, a PVI analyser, in combination with the ECGenius system, CathVision’s novel EP recording technology and amplifier. PVISION is expected to enrol 90 patients at four clinical trial sites in Belgium and France with completion by the end of 2021.
Developed by Mattias Duytschaever and Milad El Haddad at the University of Ghent, Ghent, Belgium, and bolstered by the high-quality, low-noise cardiac signals acquired by CathVision’s ECGenius System, the PVI analyser is the first and only signal-based algorithm capable of confirming PVI endpoint across multiple cardiac ablation modalities when physicians are treating complex arrhythmias like atrial fibrillation (AF), the company said in a press release.
“Today’s complex cardiac ablation procedures involve the insertion of multiple electrode catheters into the heart in order to collect and interpret thousands of cardiac signals,” said principal investigator Mattias Duytschaever, AZ Sint-Jan, Bruges, Belgium. “Because the ECGenius system provides us with exceptional low-noise, high-quality signals, we will be able to better examine the efficacy of using the PVI analyser algorithm during this particular trial to determine if electrical isolation of the pulmonary veins has been achieved. This creates the possibility of an automated, objective and standardized endpoint for the PVI procedure, which could lead to improved patient outcomes.”
“Algorithms powered by artificial intelligence will play an integral role in further developing the capabilities of EP recording technology, but the success of those algorithms and the positive impact they could have on patient outcomes is dependent on our ability as an industry to deliver EP recording technology that provides exceptional quality cardiac signals that exceed the current industry standard,” said Mads Matthiesen, CEO, CathVision. “The PVISION study is the perfect opportunity to demonstrate the importance of enhanced EP recording technology and AI algorithms in shaping the future of diagnosing, characterising and treating complex arrhythmias.”
Enrolment in PVISION is underway at AZ Sint-Jan (Bruges, Belgium), UZ Gent (Ghent, Belgium), UZ Brussel (Brussels, Belgium) and Clinique Pasteur Toulouse (Toulouse, France) with several enrolments already confirmed at each site.