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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Atrial mapping and dispersion auto-tagging with VX1+ | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| VX1+ dispersion mapping | Device | 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. |
| 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 |
| 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+ |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Julien SEITZ, MD | Hôpital Saint-Joseph Marseille | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hôpital Saint-Joseph | Marseille | 13008 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28104073 | Background | 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. | |
| 35989543 |
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| ID | Term |
|---|---|
| D001281 | Atrial Fibrillation |
| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
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Interventional, prospective, non-randomized, non-controlled, single-center clinical investigation as part of the premarket clinical evaluation of VX1+ (medical device).
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|
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 |
| Background |
| 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. |
| Result | 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 |
| D013568 |
| Pathological Conditions, Signs and Symptoms |