Clinical trial NCT05362656: AutoMatic disPERsion Tagging Function Preliminary Evaluation
Official title: Preliminary Evaluation of the Artificial Intelligence Software VX1+ for the Detection and Automatic Tagging on 3D Mapping of Spatio-temporal Dispersion Areas During Atrial Fibrillation or Atrial Tachycardia Ablation Procedures.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Atrial Fibrillation
Atrial Tachycardia
Atrial Arrhythmia
Keywords: Artificial Intelligence
Cardiac ablation
Medical device
Software
Volta Medical
Atrial Arrhythmia
Lead sponsor: Volta Medical
Sponsor class: INDUSTRY
First posted: 2022-05-05
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Interventional, prospective, non-randomized, non-controlled, single-center clinical investigation as part of the premarket clinical evaluation of VX1+ (medical device).
Primary purpose: DIAGNOSTIC

Brief summary: Interventional, prospective, non-randomized, single-center, non-controlled clinical investigation as part of the premarket clinical evaluation of VX1+ medical device, aiming to verify that VX1+ in bidirectional configuration with auto-tagging function is both ergonomic and reliable for dispersed electrograms detection and automatic tagging on 3D-map in real-time.

Detailed description: Ablation of Atrial Fibrillation (AF) and Atrial Tachycardia (AT) is typically performed in predetermined anatomic regions of the left atrium (pulmonary veins isolation) and may be supplemented by a tailored ablation approach in order to identify areas of interest specific to the patient. The VX1+ medical device is intended to assist operators in the manual or automatic real-time annotation of 3D electroanatomical maps of the heart for the presence of multipolar intra-cardiac atrial electrograms exhibiting spatio-temporal dispersion during ablation procedures.

This study will specifically allow to evaluate the peroperative performance of VX1+ automatic tagging function in bi-directional configuration with a compatible 3D mapping system.

Eligibility criteria: Inclusion Criteria:

* Patient aged 18 years or older.
* Patient candidate for catheter ablation of atrial tachycardia, or paroxysmal or persistent atrial fibrillation, de novo or after one or several previous ablation procedures.
* Continuous anticoagulation for more than 4 weeks before ablation.
* Patient giving his signed consent form to participate in the clinical study.
* Patient affiliated to the French social security

Exclusion Criteria:

* Contraindication to AF/AT catheter ablation.
* Major bleeding disorder.
* Contraindication to anticoagulation (Heparin, Warfarin or novel oral anticoagulants (NOAC)) or lack of anticoagulation for 4 weeks prior to the procedure.
* Presence of a left atrium (LA) thrombus on transesophageal echocardiography (TEE) prior to the procedure.
* Patient who is or could potentially be pregnant.
* Person deprived of liberty or under guardianship.
* Patient's refusal to participate in the study.

Primary outcomes:
measure: Perioperative reliability of VX1+ in the real-time detection of electrograms in AF or AT exhibiting a spatio-temporal dispersion, and auto-tagging of these dispersion areas on 3D electroanatomical maps.
timeFrame: During procedure
Secondary outcomes:
measure: Accuracy of VX1+ in estimating cardiac cycle lengths
timeFrame: During procedure
measure: Operators' satisfaction regarding the ergonomics of VX1+
timeFrame: Through study completion, assessed up to 4 months
measure: Preliminary safety data on VX1+ perioperatively in terms of device deficiencies, adverse events and mapping time
timeFrame: From the date of hospitalization for the ablation procedure until the date of discharge, up to 1 week
Other outcomes:
Locations:
city: Marseille
country: France
facility: Hôpital Saint-Joseph
Study officials:
affiliation: Hôpital Saint-Joseph Marseille
name: Julien SEITZ, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Seitz J, Bars C, Theodore G, Beurtheret S, Lellouche N, Bremondy M, Ferracci A, Faure J, Penaranda G, Yamazaki M, Avula UM, Curel L, Siame S, Berenfeld O, Pisapia A, Kalifa J. AF Ablation Guided by Spatiotemporal Electrogram Dispersion Without Pulmonary Vein Isolation: A Wholly Patient-Tailored Approach. J Am Coll Cardiol. 2017 Jan 24;69(3):303-321. doi: 10.1016/j.jacc.2016.10.065.
citation: Seitz J, Durdez TM, Albenque JP, Pisapia A, Gitenay E, Durand C, Monteau J, Moubarak G, Theodore G, Lepillier A, Zhao A, Bremondy M, Maluski A, Cauchemez B, Combes S, Guyomar Y, Heuls S, Thomas O, Penaranda G, Siame S, Appetiti A, Milpied P, Bars C, Kalifa J. Artificial intelligence software standardizes electrogram-based ablation outcome for persistent atrial fibrillation. J Cardiovasc Electrophysiol. 2022 Nov;33(11):2250-2260. doi: 10.1111/jce.15657. Epub 2022 Sep 18.
citation: Lotteau S, Seitz J, Bars C, et al. Bidirectional communication between an artificial intelligence device and a 3-dimensional navigation apparatus improves automation of multipolar electrogram mapping during paroxysmal and persistent atrial fibrillation. Cardiovascular Digital Health Journal. 2023;4(5):S8. doi:10.1016/j.cvdhj.2023.08.017