AutoMatic disPERsion Tagging Function Preliminary Evaluation
- Conditions
- Atrial FibrillationAtrial TachycardiaAtrial Arrhythmia
- Interventions
- Device: VX1+ dispersion mapping
- Registration Number
- NCT05362656
- Lead Sponsor
- Volta Medical
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 40
- 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
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Atrial mapping and dispersion auto-tagging with VX1+ VX1+ dispersion mapping -
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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).
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.
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 +
Trial Locations
- Locations (1)
Hôpital Saint-Joseph
🇫🇷Marseille, France