RecruitingNCT07621055

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

Real-World Experience of Volta Medical AI-software During AF Ablation Using Next-generation Mapping and Ablation Technologies

Sponsor

Volta Medical

Enrollment

150 participants

Start Date

Jun 16, 2026

Study Type

OBSERVATIONAL

Conditions

Atrial Arrhythmia Arrhythmias, Cardiac Atrial Fibrillation

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a medical device called Cardiac mapping for people with arrhythmias, cardiac, atrial arrhythmia, and other related conditions. The study is currently recruiting participants at 3 locations. People eligible for this study include aged 18 Years and older.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICECardiac 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.