Atrial Fibrillation Clinical Trial
— AMPEREOfficial 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.
Verified date | November 2023 |
Source | Volta Medical |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 40 |
Est. completion date | December 9, 2022 |
Est. primary completion date | December 9, 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
France | Hôpital Saint-Joseph | Marseille |
Lead Sponsor | Collaborator |
---|---|
Volta Medical |
France,
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. C
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. — View 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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | 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 | |
Secondary | 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 | |
Secondary | 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 |
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