Cardiac mapping: All patients enrolled are treated for their atrial fibrillation/tachycardia via a catheter ablation procedure using VX1/Volta AF-Xplorer/Volta AF-Xplorer II software (used in accordance with its approved indication as per of its IFU) during the mapping phase to identify areas of interest specific to the patient.
The ablation approach is free and chosen by the operator according to his standard practice. The two main phases of the ablation procedure are:
* 3D mapping of the atria and location of areas of interest;
* Catheter ablation at the operator\'s discretion.
Study summary
The goal of this Observational Prospective Multi-center Study is to observe the acute and long-term safety and performance outcomes after spatiotemporal dispersion-based AF/AT ablation utilizing the Volta Medical AI software in "real-life" clinical practice, without any imposed clinical workflow. Moreover, this study will allow to collect medico-economic data related to the tailored ablation strategy guided by the Volta Medical AI software.
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria:
1. Patient aged 18 years or older.
2. Patient candidate for catheter ablation to treat paroxysmal or persistent atrial fibrillation, atrial tachycardia, de novo or after one or several previous ablation procedures, and for which the investigator considers using VX1 or Volta AF-Xplorer or Volta AF-Xplorer II.
3. Patient able and willing to provide written informed consent to participate in the study.
4. Only for France: Patient affiliated to the French social security system.
Exclusion Criteria:
1. Contraindication to AF/AT catheter ablation.
2. Patient who is or could potentially be pregnant.
3. Person deprived of liberty or under guardianship.
4. Person unable to undergo a medical monitoring for geographical, social or psychological reasons.
5. Patient\'s refusal to participate in the study.
6. Enrollment in an investigational study evaluating another device, biologic, or drug.
Primary outcome measure(s)
Freedom from clinically significant AF or atrial arrhythmia recurrence, after one or multiple ablation procedures, with or without antiarrhythmic drugs, stratified by type of clinical workflow. — [24 months]
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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