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BaLloon-based PFA Ablation poST Approval Outcomes for PAF and PersAF

Study acronym: BLAST-OFF
StatusRecruiting
PhaseNot applicable
Started2025-12-11
View on ClinicalTrials.gov ↗

Amendment history

2026-05-21
Study Status, Contacts/Locations v4
Study sitesdetails revised at 4 of 22 sites
2026-04-03
Study Status, Contacts/Locations v3
Study sitesdetails revised at 2 of 22 sites
2026-03-02
Study Status, Contacts/Locations v2
Study sitesdetails revised at 10 of 22 sites
2026-01-21
Not Yet Recruiting→Recruiting Study Status, Oversight, Arms and Interventions, Contacts/Locations v1
Trial statusNot Yet Recruiting→Recruiting
Start dateestimated 2025-12→confirmed 2025-12-11
Study sites0→22
InterventionsPulsed Field Ablation (Procedure)→Pulsed Field Ablation (Device)
2025-09-12
Original filing
This study is designed to obtain real-world clinical evidence on the safety and effectiveness of the Volt PFA System in various use cases, with a sub study designed to address additional clinical evidence needs in electrophysiology.
Trial Details
NCT Number NCT07181590
Lead Sponsor Abbott Medical Devices
Conditions Paroxysmal AF, Atrial Arrhythmia, Atrial Fibrillation, Persistent Atrial Fibrillation
Enrollment 300 participants
Start Date 2025-12-11
Primary Completion 2027-08 (estimated)
Study Completion 2027-08 (estimated)
Updated on ClinicalTrials.gov 2026-05-26