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RECRUITING
NCT07621055

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

Sponsor: Volta Medical

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

OBSERVATIONAL

Enrollment

150

Start Date

2026-06-16

Completion Date

2030-06

Last Updated

2026-06-22

Healthy Volunteers

No

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.

Locations (3)

Hôpital Saint-Joseph Marseille

Marseille, France

Centre Cardiologique du Nord

Saint-Denis, France

Clinique Rhéna

Strasbourg, France