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

Sponsor
Volta Medical
Study ID
NCT07621055
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Cardiac mapping — DEVICE
    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 Details

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 Dates

First listed
Jun 2, 2026
Start date
Jun 16, 2026
Status verified
Jun 2026
Primary completion
Jun 30, 2030
Completion
Jun 30, 2030

Study Design

Enrollment
150 participants (estimated)

Primary Outcome Measure

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. [ Time Frame: 24 months ]

Central Contacts

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