AutoMatic disPERsion Tagging Function Preliminary Evaluation

Study Overview
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Brief Summary
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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
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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.

Official Title
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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.

Conditions
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Atrial Fibrillation, Atrial Tachycardia, Atrial Arrhythmia

Intervention / Treatment
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* Device: VX1+ dispersion mapping


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Interventional Model Description: Interventional, prospective, non-randomized, non-controlled, single-center clinical investigation as part of the premarket clinical evaluation of VX1+ (medical device).
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Atrial mapping and dispersion auto-tagging with VX1+<br> | Device: VX1+ dispersion mapping<br>* Careful biatrial high density dispersion mapping is performed as the first step of the procedure. Operators map each region of both atria carefully by moving the mapping catheter slowly. If VX1+ application detects dispersion regions, the corresponding dipoles location will be automatically tagged on the 3D-map. Accuracy and relevance of dispersion regions should be confirmed by the operator by checking EGMs visually.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Comparison between the automatically annotated areas with VX1+ and those annotated manually following the operator's visual analysis (true positive, false positive, false negative). | During procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Accuracy of VX1+ in estimating cardiac cycle lengths | Comparison between the cardiac cycle length values estimated by VX1+ and the values measured manually by the operator from the electrograms signals (EGM). | During procedure | 
| Operators' satisfaction regarding the ergonomics of VX1+ | Score of the operator's satisfaction and usage feedbacks regarding the ergonomics of VX1 + | Through study completion, assessed up to 4 months | 
| Preliminary safety data on VX1+ perioperatively in terms of device deficiencies, adverse events and mapping time | Rate of device deficiencies during the mapping phase, rate of Adverse Events for the hospitalization period and mapping time of dispersion areas with VX1+ device. | From the date of hospitalization for the ablation procedure until the date of discharge, up to 1 week | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Artificial Intelligence, Cardiac ablation, Medical device, Software, Volta Medical, Atrial Arrhythmia