20.05.2024 14:00:28 - dpa-AFX: EQS-News: Volta Medical presents results from first transatlantic randomized controlled trial comparing AI-assisted ablation procedure with conventional treatment for persistent atrial fibrillation patients (english)

Volta Medical presents results from first transatlantic randomized
controlled trial comparing AI-assisted ablation procedure with conventional
treatment for persistent atrial fibrillation patients

EQS-News: Volta Medical SAS / Key word(s): Study results
Volta Medical presents results from first transatlantic randomized
controlled trial comparing AI-assisted ablation procedure with conventional
treatment for persistent atrial fibrillation patients

20.05.2024 / 14:00 CET/CEST
The issuer is solely responsible for the content of this announcement.

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Volta Medical presents results from first transatlantic randomized
controlled trial comparing AI-assisted ablation procedure with conventional
treatment for persistent atrial fibrillation patients

  * TAILORED-AF trial findings demonstrated superiority in freedom from
    atrial fibrillation (AF) with or without anti-arrhythmic drugs at 12
    months from a tailored cardiac ablation guided by artificial
    intelligence (AI) when compared to pulmonary vein isolation (PVI) alone.


Marseille (France), May 20, 2024 - Volta Medical, a pioneering health-tech
company developing AI based solutions to assist electrophysiologists,
announced positive results from the transatlantic, multicenter, randomized,
controlled, superiority trial titled Tailored vs. Anatomical Ablation
Strategy for Persistent Atrial Fibrillation (TAILORED-AF) at Heart Rhythm
2024 Late Breaking Clinical Trials and Science program. Results from this
FDA IDE trial (clinicaltrials.gov NCT04702451) presented by the principal
investigator Professor Isabel Deisenhofer (Munich Heart Center, Munich
Germany), demonstrated that utilization of Volta's AI decision support
system in addition to PVI was superior to a PVI-only procedure in persistent
or long-standing persistent AF patients in attaining patient freedom from
documented AF with or without anti-arrhythmic drugs at 12 months. Volta's AI
decision support system was used to enable a tailored cardiac ablation
procedure for patients in the Tailored cohort. The AI solution is designed
to assist cardiologists with real-time identification of specific abnormal
electrograms (EGMs), known as spatio-temporal dispersed EGMs. This is the
first large-scale transatlantic randomized controlled trial of ablation in a
persistent AF population to show the benefit of an extra-pulmonary vein
procedure vs. conventional treatment of PVI-only. Previous landmark studies
looking at ablation strategies for persistent AF patients have demonstrated
a lack of a consistent ablation strategy that is effective for patients,
with a clinical success rate in past trials of 50%1.

In the clinical trial, adults with symptomatic persistent or long-standing
persistent AF who were candidates for a first-time ablation were enrolled in
Europe and the United States. A total of 187 patients underwent a tailored
cardiac ablation guided by Volta's AI technology in addition to PVI
(Tailored cohort), and 183 patients received the conventional treatment of
PVI-only (Anatomical cohort) and all were followed up for 12 months. A total
of 51 electrophysiologists at 26 centers in 5 countries participated. The
trial met the primary endpoint by demonstrating superiority in patients
assigned to the Tailored cohort compared to the Anatomical cohort. 88% of
patients in the Tailored cohort experienced freedom from AF 12 months post
procedure with or without anti-arrhythmic drugs compared to 70% in the
anatomical cohort. Additionally, 66% of patients in the Tailored arm
experienced termination of acute AF, compared to 15% of patients in the
Anatomical arm. The trial also examined several pre-specified secondary
endpoints and a pre-specified subgroup of patients with sustained persistent
AF lasting 6 months or longer prior to enrollment. Patients in the Tailored
cohort experienced a higher rate of freedom from any arrhythmia after 1.2
procedures, particularly for patients with sustained persistent AF >= 6
months.

About Atrial Fibrillation

The American Heart Association (AHA) defines atrial fibrillation (AF) as an,
irregular heartbeat (arrhythmia) that can lead to blood clots, stroke, heart
failure and other heart-related complications.2 Approximately 33 million
patients worldwide are living with AF.3,4 Even though untreated AF doubles
the risk of heart-related deaths and is associated with a 5-fold increased
risk for stroke, many patients are unaware that AF is a serious condition.

About Volta Medical

Volta Medical is a health-tech company developing artificial intelligence
software solutions created to assist cardiac electrophysiologists during
arrhythmia treatment procedures to improve clinical outcomes for patients.
Founded by three physicians and a data scientist in 2016 and based in
Marseille, France, the company's mission is to improve cardiac arrhythmia
management by developing state-of-the-art, data-driven medical devices
trained on large databases of procedural data. The Volta AF Xplorer(TM) is a
digital AI companion designed to assist cardiologists with real-time
identification of specific abnormal electrograms (EGMs) known as
spatio-temporal dispersed EGMs during AF and atrial tachycardia procedures.
The AF-Xplorer(TM) has been engineered for versatility and its use has been
demonstrated with the most popular AF mapping and recording systems, as well
as with the most common ablation modalities. The company has obtained U.S.
FDA 510(k) clearance* and European CE Mark approval for its innovative
products. For more information, visit the company's website at
www.volta-medical.com.

* The clinical significance of utilizing the Volta AF-Xplorer(TM) software for
catheter ablation of atrial arrhythmias has not been reviewed by the FDA.

Volta Contact
Jeff Martin, SVP of Global Marketing
Volta Medical
jeffrey.martin@volta-medical.com

Europe Media Contact
Brittney Sojeva
MC Services AG
Volta-medical@mc-services.eu

References
____________________

  1. Verma, Atul, et al. "Approaches to catheter ablation for persistent
    atrial fibrillation." New England Journal of Medicine 372.19 (2015):
    1812-1822.


  2. https://www.heart.org/en/health-topics/atrial-fibrillation (last
    accessed June 9, 2023)


  3. Colilla S, Crow A, Petku W, Singer DE, Simon T, Liu X. Estimates of
    current and future incidence and prevalence of atrial fibrillation in
    the U.S. adult population. Am J Cardiol 2013; 112:1142-1147. DOI:
    10.1016/j.amjcard.2013.05.063


4. https://kompetenznetz-vorhofflimmern.de/en (last accessed June 9, 2023)


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20.05.2024 CET/CEST Dissemination of a Corporate News, transmitted by EQS
News - a service of EQS Group AG.
The issuer is solely responsible for the content of this announcement.

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   Language:       English
   Company:        Volta Medical SAS
                   65 Avenue Jules Cantini
                   13006 Marseille
                   France
   E-mail:         contact@volta-medical.com
   Internet:       www.volta-medical.com
   EQS News ID:    1906291




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