Clinical Trial

Evaluation of the FARAFLEX Mapping and Pulsed Field Ablation System in Subjects With Atrial Fibrillation

Study acronym: FARADIGM
Recruiting
View on ClinicalTrials.gov →
Summary
The goal of this clinical trial is to learn if the FARAFLEX™ Mapping and pulsed field ablation (PFA) System can safely and effectively treat symptomatic, drug-refractory Paroxysmal atrial fibrillation (PAF) and Persistent atrial fibrillation (PersAF). The main question it aims to answer is: Is the FARAFLEX Mapping and PFA System a safe and effective treatment for patients? Participants will undergo an ablation procedure using the FARAFLEX Mapping and PFA System.
Protocol Amendment History 8 changes
notable Trial sites expanded: 1 -> 6 locations 2026-07-28
notable Primary completion pushed: 2028-06-12 -> 2028-07-20 2026-07-28
critical Trial status changed: Withheld → Recruiting 2026-06-03
critical Phase changed: not specified -> not applicable 2026-06-03
critical Primary endpoint(s) modified 2026-06-03
notable Enrollment changed: None -> 571 2026-06-03
notable Sponsor changed: [Redacted] -> Boston Scientific Corporation 2026-06-03
minor Trial arms changed: 0 -> 1 2026-06-03
Trial Details
NCT Number NCT07575269
Lead Sponsor Boston Scientific Corporation
Conditions Paroxysmal Atrial Fibrillation (PAF), Persistent Atrial Fibrillation
Enrollment 571 participants
Start Date 2026-07-07
Primary Completion 2028-07-20 (estimated)
Study Completion 2030-01-01 (estimated)
Updated on ClinicalTrials.gov 2026-08-06