Clinical Trial

Pulmonary Vein Isolation Alone or in Combination With Substrate Modulation After Electric Cardioversion Failure

Study acronym: PACIFIC
Recruiting
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Record status
This record was last updated April 24, 2024 (before its estimated April 1, 2025 completion). Its status may not reflect the trial's current state.
Summary
This study aims at assessing whether electric cardioversion can act as a discriminant factor between patients requiring Pulmonary Vein Isolation (PVI) procedure alone or PVI procedure combined with substrate modulation. All included patients will undergo an electric cardioversion, then: * Patients with electric cardioversion success will be treated as per Standard of Care and according to ESC recommendations (2020). A prospective registry will be implemented for these patients. * Patients with electric cardioversion failure will be randomized in the study between 2 ablative procedures: * PVI procedure alone * PVI procedure combined with substrate modulation
Protocol Amendment History 6 amendments
This ClinicalTrials.gov record has been amended 6 times since 2022-03-02; most recent amendment 2024-04-23.
Status change: Not Yet Recruiting → Recruiting 2023-02-22
Trial Details
NCT Number NCT05264831
Lead Sponsor Elsan
Conditions Persistent Atrial Fibrillation
Enrollment 450 participants
Start Date 2023-02-20
Primary Completion 2025-04-01 (estimated)
Study Completion 2027-10-01 (estimated)
Updated on ClinicalTrials.gov 2024-04-24