VOLta Medical AI-software in REal-World During AF Ablation
NCT07621055 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 150
Last updated 2026-06-22
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.
Conditions
- Atrial Fibrillation
- Atrial Arrhythmia
- Arrhythmias, Cardiac
Interventions
- DEVICE
-
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.
Sponsors & Collaborators
-
Volta Medical
lead INDUSTRY
Principal Investigators
-
Clément BARS, MD · Hôpital Saint Joseph Marseille
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2026-06-16
- Primary Completion
- 2030-06-30
- Completion
- 2030-06-30
Countries
- France
Study Locations
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