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ACTIVE NOT RECRUITING
NCT06083012

Clinical and Healthcare Economic OutcoMes From ReAl-worlD Use in Europe of an AI Software During AF Ablation

Sponsor: Volta Medical

View on ClinicalTrials.gov

Summary

The goal of this Observational Prospective Multi-center Study is to observe the acute and long-term safety and performance outcomes after spatiotemporal dispersion-based AF/AT ablation utilizing the Volta Medical AI software in "real-life" clinical practice, without any imposed clinical workflow. Moreover, this study will allow to collect medico-economic data related to the tailored ablation strategy guided by the Volta Medical AI software.

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

OBSERVATIONAL

Enrollment

186

Start Date

2023-10-27

Completion Date

2027-04-27

Last Updated

2026-01-15

Healthy Volunteers

No

Interventions

DEVICE

Cardiac mapping

All patients enrolled are treated for their atrial fibrillation/tachycardia via a catheter ablation procedure using VX1/Volta AF-Xplorer/Volta AF-Xplorer II software (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 (7)

Hôpital Saint-Joseph

Marseille, France

Hôpital Privé Jacques Cartier

Massy, France

Polyclinique Saint George

Nice, France

Centre Cardiologique du Nord

Saint-Denis, France

Clinique Rhéna

Strasbourg, France

Clinique Pasteur

Toulouse, France

German Heart Center Munich

München, Germany