Clinical Trial

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

Study acronym: COMRADE-AI
Active, Not Recruiting
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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.
Protocol Amendment History 3 amendments
This ClinicalTrials.gov record has been amended 3 times since 2023-10-09; most recent amendment 2026-01-14.
Status change: Recruiting → Active, Not Recruiting 2026-01-14
Status change: Not Yet Recruiting → Recruiting 2023-11-21
Trial Details
NCT Number NCT06083012
Lead Sponsor Volta Medical
Collaborators: Fortrea
Conditions Atrial Fibrillation, Atrial Arrhythmia, Arrhythmias, Cardiac
Enrollment 186 participants
Start Date 2023-10-27
Primary Completion 2027-04-27 (estimated)
Study Completion 2027-04-27 (estimated)
Updated on ClinicalTrials.gov 2026-01-15