Cardiac mapping: All patients enrolled are treated for their atrial fibrillation/tachycardia via a catheter ablation procedure using the last generation of Volta Medical AI software (Volta AF-Xplorer II, 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
This PMCF study "VOLTAIRE-AF" will allow to observe acute and long-term safety and performance outcomes of the last generation of Volta Medical AI software (Volta AF-Xplorer II) during AF ablation using next-generation mapping and ablation technologies over a 24-month follow-up and in "real life"clinical practice, without any imposed clinical workflow.
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 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 using RF and/or PFA.
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 a premarket clinical study evaluating device, drug or biologic product.
Primary outcome measure(s)
Freedom from clinically significant AF or atrial arrhythmia recurrence, after one or multiple ablation procedures, with or without antiarrhythmic drugs, at 12 and 24 months. — 24 months An Atrial Arrhythmia episode (AF/AFL/AT ≥ 30s) will be determined to be clinically significant if it results in an unexpected treatment change (e.g. new anti-arrhythmic drug or higher dose of AAD, repeat ablation procedure, DC cardioversion), or if it is accompanied by worsening of symptoms related to AF, considering a standard 3-month blanking period.
Volta AF-Xplorer II-related Serious Incident rate — 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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