Atrial Arrhythmia, Atrial Fibrillation, Atrial Tachycardia
Conditions
Keywords
Artificial Intelligence, Cardiac ablation, Medical device, Software, Volta Medical, Atrial Arrhythmia
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.
Interventions
DEVICEVX1+ dispersion mapping
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.
Sponsors
Volta Medical
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Intervention model description
Interventional, prospective, non-randomized, non-controlled, single-center clinical investigation as part of the premarket clinical evaluation of VX1+ (medical device).
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. | During procedure | Comparison between the automatically annotated areas with VX1+ and those annotated manually following the operator's visual analysis (true positive, false positive, false negative). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Accuracy of VX1+ in estimating cardiac cycle lengths | During procedure | Comparison between the cardiac cycle length values estimated by VX1+ and the values measured manually by the operator from the electrograms signals (EGM). |
| Operators' satisfaction regarding the ergonomics of VX1+ | Through study completion, assessed up to 4 months | Score of the operator's satisfaction and usage feedbacks regarding the ergonomics of VX1 + |
| Preliminary safety data on VX1+ perioperatively in terms of device deficiencies, adverse events and mapping time | From the date of hospitalization for the ablation procedure until the date of discharge, up to 1 week | 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. |
Countries
France
Outcome results
None listed