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A Global Study Comparing Pulsed Field Ablation With Electrographic Flow Mapping Versus Posterior Wall Ablation for Persistent Atrial Fibrillation

Study acronym: OPTIMIZE
StatusActive, Not Recruiting
PhaseNot applicable
Started2025-11-07
View on ClinicalTrials.gov ↗

Amendment history

2026-09-25
Primary completion moved earlier: 2028-07 → 2027-01
Completion moved earlier: 2030-12 → 2027-01
2026-08-26
Study Status v10
Re-verified, no change to tracked fields
2026-07-28
Study Status, Contacts/Locations v9
Enrollment closed, study ongoing
Trial sites reduced: 42 → 15 locations
2026-06-29
Study Status, Contacts/Locations v8
Study sites41→42
2026-05-26
Study Status, Contacts/Locations v7
Study sites39→41
Show 6 earlier versions
2026-04-29
Study Status, Contacts/Locations v6
Study sites37→39
2026-03-26
Study Status, Contacts/Locations v5
Study sites37 entries, revised
Onze Lieve Vrouw ZiekenhuisAZORG
2026-02-26
Study Status, Contacts/Locations v4
Study sitesdetails revised at 2 of 37 sites
2026-01-27
Study Status, Contacts/Locations v3
Study sitesdetails revised at 1 of 37 sites
2025-12-22
Study Status, Contacts/Locations v2
Study sites37 entries, revised
Grandview Medical Center Affinity Cardiovascular Specialists, LLC An Affiliate of Grandview Health/Grandview Medical Center Dignity Health Mercy Gilbert Medical Center Alta Bates Summit Medical Center - Summit Campus St. Luke's Clinic - Idaho Cardiology Associates Heart Rhythm Center: Boise Mount Sinai Medical Center Good Samaritan Hospital - Suffern Memorial Mission Hospital Sacred Heart Medical Center at Riverbend-Hospital Presbyterian HospitalUniversity of Pennsylvania Medical Center AZORGOnze Lieve Vrouw Ziekenhuis - Campus Moorselbaan
2025-11-21
Withheld→Recruiting Study Identification, Study Status, Sponsor/Collaborators, Oversight, Study Description, Conditions, Study Design, Arms and Interventions, Outcome Measures, Eligibility, Contacts/Locations v1
Trial statusWithheld→Recruiting
Primary completion datenot stated→2028-07
Completion datenot stated→2030-12
Start datenot stated→2025-11-07
Lead sponsor[Redacted]→Boston Scientific Corporation
Study title+80 characters
[TrialA ofGlobal deviceStudy thatComparing isPulsed notField approvedAblation orWith clearedElectrographic byFlow theMapping U.S.Versus FDA]Posterior Wall Ablation for Persistent Atrial Fibrillation
2025-09-15
Original filing
The purpose of this study is to establish the safety of the pulsed field ablation (PFA) therapy of Pulmonary Veins and Electrographic Flow (EGF) identified extra-PV sources of atrial fibrillation (PVI + EGF ablation of sources) and to demonstrate its non-inferiority in effectiveness compared to PFA of Pulmonary Veins and LA Posterior Wall (PVI+ PWA) in the treatment of de novo symptomatic drug-refractory persistent atrial fibrillation (PersAF).
Trial Details
NCT Number NCT07187115
Lead Sponsor Boston Scientific Corporation
Conditions Atrial Fibrillation (AF), Persistant Atrial Fibrillation
Enrollment 699 participants
Start Date 2025-11-07
Primary Completion 2027-01 (estimated)
Study Completion 2027-01 (estimated)
Updated on ClinicalTrials.gov 2026-09-24