Clinical Trial

Extended Ablation Versus Pulmonary Vein Isolation to Treat Persistent Atrial Fibrillation

Study acronym: EXTEND-PVI
Not Yet Recruiting
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Summary
The aim is to determine the effect of extended ablation (pre-specified linear PF/RF lesion set) in addition to PVI in symptomatic persistent AF patients on AF/AT/AFL recurrence. The study is designed as multicenter, randomized trial. Eligible patients are patients with persistent AF (but not long-standing persistent AF) planned for a first-ever AF ablation procedure. Patients will be randomly assigned 1:1 either to: i) PVI-only, or ii) PVI-plus arms. Patients in both groups will undergo catheter ablation using an ablation system capable of performing PF and RF ablation (Sphere-9, Affera, Medtronic). Patients randomized to the PVI-only arm will undergo only PVI. Patients randomized to the PVI-plus arm will undergo PVI plus linear lesions (roof, bottom line, lateral or anterior MI line, and septal line in the LA; intercaval line and cavotricuspid line in the RA). The primary endpoint will be freedom from recurrent AF/AT/AFL, assessed as time-to-first recurrence in the period of 12 months after randomization (post 2-month blanking period). Secondary clinical endpoints will be 1) 12-month differences in AF/AT/AFL burden, 2) AF/AFL/AT-related outcomes (hospitalization or emergency visits), 3) Quality of life according to the AFEQT questionnaire score at 12 months, 4) MACE defined as cardiovascular death, stroke, myocardial infarction, or hospitalization for heart failure. Secondary endpoints will be evaluated throughout the entire (minimum 12-month) follow-up period.
Trial Details
NCT Number NCT07424326
Lead Sponsor Charles University, Czech Republic
Collaborators: Institute for Clinical and Experimental Medicine, University Hospital Olomouc, Cardiocenter Podlesí, Trinec, Czech Republic, Faculty Hospital Kralovske Vinohrady
Conditions Atrial Fibrillation (AF)
Enrollment 450 participants
Start Date 2026-06-01
Primary Completion 2029-12-31 (estimated)
Study Completion 2029-12-31 (estimated)
Updated on ClinicalTrials.gov 2026-02-20