VOLta Medical AI-software in REal-World During AF Ablation

Recruiting now

Conditions studied: Atrial Fibrillation, Atrial Arrhythmia, Arrhythmias, Cardiac

In brief

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.

Key facts

Study ID

NCT07621055

Run by

Volta Medical

People needed

150

Starts

2026-06-16

Expected to finish

2030-06-01

Last updated by the study team

2026-06-22

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.
• Enrollment in a premarket clinical study evaluating device, drug or biologic product.

Where it is running

• Hôpital Saint-Joseph Marseille — Marseille, France (enrolling)
• Centre Cardiologique du Nord — Saint-Denis, France
• Clinique Rhéna — Strasbourg, France

Full record on ClinicalTrials.gov

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