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.
symptomatic persistent AF
≥1 episode of persistent AF in the last 12 months
signed informed consent
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
Parallel
PVI-plus
Procedure/SurgeryPatients 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/SurgeryPatients randomized to the PVI-only arm will undergo only PVI.
Freedom from AF, AT and AFL
Freedom from recurrent atrial fibrillation, atrial tachycardia, or atrial flutter, assessed as time-to-first recurrence. An episode of atrial fibrillation, atrial tachycardia or atrial flutter is defined as either (1) a recording demonstrating at least 30 seconds of continuous interpretable signal during Holter monitoring performed at 3, 6, 9, or 12 months, or (2) a 12-lead ECG demonstrating the arrhythmia throughout the entire tracing, with at least 10 seconds of continuous interpretable signal during scheduled or emergency visits.
AF/ AT/AFL burden
The percentage of total monitoring time spent in atrial fibrillation, atrial tachycardia, or atrial flutter during Holter recordings at 3, 6,9 and 12 months.
AF-related clinical outcomes
All emergency visits or hospitalizations due to documented recurrence of AF/AFL/AT during the whole study course
Quality of life
The quality-of-life differences in AFEQT (AF Effect on Quality-of-Life Questionnaire) scores between the 12-month visit and the randomization visits will be compared between the study arms.
MACE
Major adverse clinical outcomes (MACE), a composite of cardiovascular death, stroke, myocardial infarction, or hospitalization for heart failure during the whole study course
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Charles University, Czech Republic
Lead sponsor
University Hospital Prague (IKEM), Prague, Czech Republic
Collaborator
University Hospital Olomouc
Collaborator
Cardiocenter Podlesí, Trinec, Czech Republic
Collaborator
Faculty Hospital Kralovske Vinohrady
Collaborator
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