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