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Extended Ablation Versus Pulmonary Vein Isolation to Treat Persistent Atrial Fibrillation

Sponsor: Charles University, Czech Republic • ClinicalTrials.gov ID: NCT07424326

Registry updated: 2026-09-24

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Description

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) 1) AF/AT/AFL burden during the first 12 months after randomization, 2) 2) Quality of life according to the AFEQT questionnaire score at 12 months, 3) 3) AF/AFL/AT-related outcomes (hospitalization or emergency visits), 4) MACE defined as cardiovascular death, stroke, myocardial infarction, or hospitalization for heart failuree, 5) A composite of pre-specified, procedure-related SAE within 7 days after the procedure, including clinically relevant delayed SAEs adjudicated as related to the index ablation procedure. Secondary endpoints will be evaluated throughout the entire (minimum 12-month) follow-up period.

Interventions

PVI-plus (Procedure)
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).
PVI-only (Procedure)
Patients randomized to the PVI-only arm will undergo only PVI.

Eligibility criteria

Inclusion Criteria: * symptomatic persistent AF * ≥1 episode of persistent AF in the last 12 months * signed informed consent Exclusion Criteria: * first-manifested AF, paroxysmal AF, long-standing persistent AF, permanent AF * SR on admission without Class I/III AADs * AF of secondary cause (e.g. hyperthyroidism) * any previous LA ablation * severe valvular disease (mitral valve insufficiency ≥3+, moderate or severe aortic stenosis) or history of valvular surgery or intervention * left ventricular ejection fraction ≤40% * pulmonary hypertension (estimated systolic pulmonary artery pressure ≥40 mm Hg) * symptomatic coronary artery disease * pregnancy * LA anteroposterior diameter ≥55 mm * body mass index ≥40 kg/m2 * age ≥80 years * chronic kidney disease stage 3b or higher * contraindication to anticoagulation * general contraindications of catheter ablation * life expectancy \<2 years due to other comorbidities

Conditions

Atrial Fibrillation (AF)

Locations

University Hospital Olomouc — Olomouc, Czechia
IKEM — Prague, Czechia
Cardiocenter, 3rd Medical School, Charles University and University Hospital Kralovske Vinohrady — Prague, Czechia
University Hospital Kralovske Vinohrady — Prague, Czechia

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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

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