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

NCT06083012 · Status: ACTIVE_NOT_RECRUITING · Type: OBSERVATIONAL · Enrollment: 186

Last updated 2026-01-15

No results posted yet for this study

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.

Conditions

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.

Sponsors & Collaborators

  • Fortrea

    collaborator INDUSTRY

  • Volta Medical

    lead INDUSTRY

Principal Investigators

  • Julien SEITZ, MD · Hôpital Saint Joseph Marseille

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-10-27
Primary Completion
2027-04-27
Completion
2027-04-27

Countries

  • France
  • Germany

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06083012 on ClinicalTrials.gov