For the treatment, in the operating room, of atrial fibrillation, the most complex and most common arrhythmia in the world
11 French research centers have already joined the study in 2021
The first results will be published in Q3 2023
MARSEILLE, France – ( BUSINESS WIRE ) – Volta Medical, an innovative French MedTech working on new artificial intelligence (AI) algorithms for the management of various cardiac arrhythmias, is rapidly expanding its network of hospitals in France with its AI software VX1 mainly as part of its TAILORED-AF study for the treatment, in the operating room, of atrial fibrillation (AF). In all, 12 French hospitals are using the technology, including 11 investigator centers in this clinical study.
TAILORED-AF is an international, multi-center, randomized 2-arm study designed to compare the ablation strategy based on the use of AI VX1 software with conventional anatomical ablation approaches that are currently in use. The study plans to include 344 patients (172 in each group / arm) and their follow-up over 12 months. The current investigative centers are the Louis Pradel Cardiological Hospital – Hospices Civils de Lyon, the Pôle Santé République in Clermont-Ferrand, the Saint Philibert Hospital in ‘Lomme, the Saint-Joseph Hospital in Marseille, the Jacques Cartier Private Hospital in Massy, the Confluent Private Hospital in Nantes, the Saint George Polyclinic in Nice, the Rhéna Clinique in Strasbourg, the North Cardiological Center in Saint Denis, the Pasteur Clinic in Toulouse, and the Lorraine Institute of the Heart and Vessels – CHRU Nancy in Vandoeuvre-Lès-Nancy. The primary endpoint of the study is the absence of documented AF, with or without antiarrhythmic drugs, 12 months after a single first ablation procedure. The first results of the study are expected in Q3 2023. “This new study is an important step in demonstrating the superiority of our AI software in the treatment of AF in the operating room, ” explains Paola Milpied, VP, Clinical and Regulatory Affairs.
Dr. Jean-Paul Albenque, cardiologist, Clinique Pasteur, Toulouse, French coordinator of the Tailored-AF study emphasizes: “The VX1 is a promising tool for identifying areas sustaining atrial fibrillation. Its interest is in particular to optimize the collection. abnormal signals that would not have been identified with standard approaches. The first results are very encouraging and this technological innovation should allow better ablative management of non-paroxysmal atrial fibrillation. The studies underway should confirm our hopes. “
the Dr. Jerome Lacotte , Cardiologist, rhythm specialist within the Cardiovascular Institute Paris Sud (ICPS) i , one of the investigators of the TAILORED-AF study: “We have been waiting for 15 years for a software solution capable of helping us in the analysis of electrical signals in order to facilitate the ablation of persistent AF, the ablation of which by the traditional technique of disconnecting the pulmonary veins remains disappointing, with less half of the patients improved, requiring a repetition of the interventions with extensive ablation strategies sometimes dilapidated. Volta Medical’s AI software is amazing because we were able to interrupt atrial fibrillation by ablation in all patients with the impression of limiting the extent of treatment, to focus on the most critical areas and thus preserve the areas healthy. Volta combines the advantage of intuitive and fluid software support that improves response efficiency without the constraint of a technically complex or disruptive solution to habits and workflow. As for the patients, all understood that this AI-based technology could help and facilitate the work of the practitioner and lead to a better result. None refused the use of Volta in the context of the Tailored-AF clinical study ”.
“Atrial fibrillation currently affects more than 30 million patients worldwide. The growing number of centers using our technology, particularly within the framework of the randomized study, testifies to a very strong adoption by cardiologists and comes to the crown of many years of work. We are continuing to expand our network of investigative centers in order to allow more and more patients to benefit from the latest innovations for the automation and simplification of the medical procedure for treating atrial fibrillation ”, add Paola Milpied and Théophile Mohr Durdez , Director general and co-founder.
Atrial fibrillation (AF)
AF consists of the heart contracting in an irregular, rapid and irregular manner. These chaotic contractions prevent the heart from pumping blood properly. The cause is an “electrical storm” in the atria. AF increases the likelihood of having a stroke four to five times, and AF-induced strokes are usually associated with more severe injuries ii . In addition, recent studies show that 20-30% of patients with ischemic stroke suffered from AF before, during or after the initial event iii .
AF is an extremely costly public health problem iv , affecting 33.5 million people worldwide, a prevalence that is set to double by 2060 v . In the EU, around 11 million people suffer from it and this number is expected to rise to 14 to 17 million by 2030 vi , with 120,000 to 215,000 new cases expected each year. Evidence suggests a higher prevalence of AF in patients with hypertension, heart failure, coronary artery disease, obesity, or diabetes. AF is the most common cardiac arrhythmia in the world and its prevalence increases with age vii .
About VX1 AI Software VX1 is AI
software, compatible with most multipolar catheters and technologies currently available that are used in the operating theater or in electrophysiology laboratories. VX1 aims to help cardiologists understand the complexity of the medical procedure for treating atrial fibrillation in real time by detecting abnormal electrical signals, sources of atrial fibrillation. The VX1 is a medical device authorized by the FDA and having obtained the CE mark.
About Volta Medical
Founded by three doctors and a data scientist in Marseille in 2016, Volta Medical is a HealthTech company that develops AI-based solutions to assist rhythmologists in the operating room.
For more information, visit the company’s website at: www.volta-medical.com
i ICPS is a world technical and scientific reference center, in particular for innovation, research and training https://icps.fr/
ii https://www.ahajournals.org/doi/10.1161/strokeaha .115.012004
iii Authors / Task Force Members: et al. “2016 ESC Guidelines for the management of atrial fibrillation developed in collaboration with EACTS.” EP Europace 18.11 (2016): 1609-1678.
v Krijthe, Bouwe P., et al. “Projections on the number of individuals with atrial fibrillation in the European Union, from 2000 to 2060.” European heart journal 34.35 (2013): 2746-2751.
vi2017 ESC Guidelines for the management of atrial fibrillation developed in collaboration with EACTS. European Heart Journal. 2016; 37: 2893–2962.doi: 10.1093 / eurheartj / ehw210
vii The average treatment amounts to € 3,000 / year / patient in France (i.e. 2.5 billion euros / year in France with hospitalizations representing half of the costs ) (Medscape).