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

Study acronym: FARADIGM
StatusRecruiting
PhaseNot applicable
Started2026-07-07
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 38 days later Jun 12, 2028 → Jul 20, 2028
See other at-risk trials from Boston Scientific Corporation

Amendment history

2026-08-26
Study Status, Contacts/Locations v6
Trial sites expanded: 9 → 12 locations
Trial sites expanded: 6 → 9 locations
2026-08-04
Study Status v5
Start date2026-07-20→2026-07-07
2026-07-24
Study Status, Contacts/Locations v4
Trial sites expanded: 1 → 6 locations
Primary completion pushed: 2028-06-12 → 2028-07-20
Start dateestimated 2026-06-12→confirmed 2026-07-20
2026-06-25
Study Status v3
Re-verified, no change to tracked fields
2026-05-29
Study Identification, Study Status, Sponsor/Collaborators, Oversight, Study Description, Conditions, Study Design, Arms and Interventions, Outcome Measures, Eligibility, Contacts/Locations v2
Trial status changed: Withheld → Recruiting
Phase changed: not specified → not applicable
Primary endpoint(s) modified
Enrollment changed: None → 571
Sponsor changed: [Redacted] → Boston Scientific Corporation+19 characters
Was[Redacted]
NowBoston Scientific Corporation
Trial arms changed: 0 → 1
Primary completion datenot stated→2028-06-12
Completion datenot stated→2030-01-01
Start datenot stated→2026-06-12
Study title+39 characters
[TrialEvaluation of device that is not approved or cleared by the U.S.FARAFLEX FDA]Mapping and Pulsed Field Ablation System in Subjects With Atrial Fibrillation
2026-05-26
Study Status v1
Re-verified, no change to tracked fields
2026-05-04
Original filing
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.
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 2026-09-24