Real-World Use of AI Software During Ablation for Atrial Fibrillation
Observes safety and performance of AI mapping software during atrial fibrillation ablation in adults.
Plain-language title generated from the registry record
Registry title: VOLta Medical AI-software in REal-World During AF Ablation
Key facts
- Where
- Marseille, Saint-Denis, and Strasbourg, FranceSee the 3 sites
Where in France
- Hôpital Saint Joseph MarseilleMarseille, FranceTaking people
- Centre Cardiologique du NordSaint-Denis, FranceNot yet recruiting
- Clinique RhénaStrasbourg, FranceNot yet recruiting
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Volta Medical
- Trial code
- NCT07621055
- Record updated
- 22 June 2026
- Original description
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.Read full original descriptionShow less
Real-World Experience of Volta Medical AI-software During AF Ablation Using Next-generation Mapping and Ablation Technologies
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.
Inclusion: Patient aged 18 years or older; 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; Patient able and willing to provide written informed consent to participate in the study; Only for France: Patient affiliated to the French social security system.
Exclusion: Enrollment in a premarket clinical study evaluating device, drug or biologic product; Contraindication to AF/AT catheter ablation using RF and/or PFA; Patient who is or could potentially be pregnant; Person deprived of liberty or under guardianship; Person unable to undergo a medical monitoring for geographical, social or psychological reasons; Patient's refusal to participate in the study.