VX1 is a novel AI support software designed to assist cardiac electrophysiologists performing catheter ablation procedures in patients with atrial fibrillation by identifying areas of abnormal signals during the mapping phase. The platform is being evaluated in the TAILORED-AF trial.
Theophile Mohr-Durdez, CEO of Volta Medical, spoke with DocWire News about his company’s mission and VX1, their AI support tool for cardiac electrophysiologists.
DW: What is the background of Volta Medical?
TM: Volta Medical is a company that I co-founded with 3 physicians, 3 cardiac electrophysiologist in 2016, and we are developing AI solutions to guide cardiac electrophysiologist while they are ablating patients with cardiac arrhythmias. And we co-founded this company to develop an initial product that is now C-marked and FDA-cleared, which is named VX1, that is aimed at guiding cardiac electrophysiologist while they’re ablating patients with atrial fibrillation.
DW: What motivated the creation of an AI solution for AF ablation?
TM: Initially, my 3 physician co-founders, I am myself a data scientist, and so when we met, they had developed a very specific expertise, a clinical expertise in identifying abnormal electrograms, abnormal signals, during AF ablation procedures. And these electrograms helped them to target specific regions in the heart, and upon ablation of this region they would reach very good acute and long-term outcomes for their patients. So essentially, they had developed a clinical expertise to tailor AF ablation and to obtain very good results, even in very complex patients; what we call persistent AF patients, patients that have been in AF since quite a long time, or patients in whom a first ablation had already failed. And so the initial goal of the development of VX1 and of the development of the company was to try to mimic this human expertise in identifying abnormal regions in the heart.
DW: How does VX1 aid current ablation strategies?
TM: VX1 is an AI software solution that was trained on a very large and representative database of electrograms that were annotated by cardiac electrophysiologists, and this solution can integrate in any EP lab in the world. It is very versatile, it is compatible with all the main catheters that are being used on the market, all the main mapping systems that are being used on the market, and all the main acquisition systems. So it does not change the current tools that are being used in the EP lab, and it integrates very easily and it basically identifies abnormal electrograms during AF ablation interventions. So, an AF ablation consists, as you know, in introducing flexible catheters through the veins, and there are essentially 2 distinct phases in the intervention. In the first phase, physicians try to understand cardiac arrhythmias. They map the chambers of the heart, and they understand, they try to understand where AFib originates from, where, which regions perpetuate the arrhythmia; and once this is understood, they come with other catheters to ablate this specific region, to cauterize the specific regions. And VX1 works during the first phase and brings additional intelligence. It works really as a companion, and it brings intelligence to understand where abnormal electrograms are located
DW: VX1 is being evaluated in the TAILORED-AF trial, what is the objective of the study?
TM: So TAILORED-AF is a randomized clinical trial that comes on the heels of another multi-centric single-armed trial that was published in the JCE last year, and where we managed to show that this software helps to standardize this tailored approach for AF ablation, and also that we managed, with this software, to have very promising results in terms of long-term outcomes for the patients. And so, on the heels of this initial trial that was published last year, we decided to launch and conduct 1 of the most ambitious randomized clinical trials in the history of AF ablation, and this is TAILORED-AF. So TAILORED-AF has started in 2021; this is a superiority trial involving 30 centers, more than 50 physicians, and this trial has been conducted in 5 countries: in France, in Germany, in the Netherlands, in Belgium, and in the USA. So this trial is a very ambitious trial with 374 patients and with a very stringent follow up that is a 12-month follow up. And the goal is to demonstrate superiority against the standard of care.
DW: How might VX1 change electrophysiology care if TAILORED-AF is successful?
TM: So obviously, the introduction of a new technology on the market takes some time, and we have, very, we have several validation steps; we have several large and ambitious clinical trials that we have been conducting in the past years. But, especially with TAILORED-AF, we think that we’ll be able to really change the way persistent AF patients are being taken care of and ablated. We think that these results might lead to a much larger use and systematic use of VX1 for persistent AF patients. This trial is focused on persistent atrial fibrillation patients, but obviously on the long term, this tool could also be used for redo patients, patients in whom first ablation has failed, and also for paroxysmal patients to adapt maybe a linear approach or a segmentation approach. It could also potentially be used to triage patients and to sort patients, to sort patients out. But yes, anyway, this tool can, definitely, be used as as a new standard of care, as an adjunct to PVI, for complex patients.
DW: What’s next for VX1?
TM: So first of all, practical next steps. We have another trial that we are going to launch anytime soon, which is going to be mainly a US trial, for patients with previous failed ablations, for redo patients. This trial is going to be focused on patients with isolated pulmonary veins. So this is typically a population where physicians don’t really know what they should do, and where VX1 can be, obviously, extremely helpful because it offers additional analytics and additional insights during the procedure. So this is a first practical next step, but then on top of this, we are also developing various other algorithms to continue to help physicians in cardiac arrhythmia ablation; for atrial fibrillation, but also for other cardiac arrhythmias such as atrial tachycardias and ventricular tachycardia.
DW: What is the goal of your team moving forward?
TM: So really, we, we think that AI can make a dent in the cardiac EP market, and we think that every, every single intervention is currently a missed opportunity in terms of what is learned. When a physician goes into the lab and does a procedure, obviously, he himself or herself learns from it, but nobody else really learns from it, and this is a missed opportunity in terms of experience, and we want to try to seize this missed opportunity and to leverage on it to build new-generation products that will, yes, that will be driven and focused on improving outcomes for patients.