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.
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
An episode of AF/ AT/AFL 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. In addition to a documented AF/AT/AFL episode as defined above, treatment failure (a primary endpoint event) will also be considered to have occurred if, after the end of the blanking period, any of the following occurs: (a) initiation or continuation of a Class I or Class III antiarrhythmic drug, or of sotalol, irrespective of the indication; (b) electrical cardioversion for AF/AT/AFL; (c) a repeat (redo) ablation for AF/AT/AFL. Beta-blockers and calcium-channel blockers do not constitute treatment failure.
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
Number of patients with a need for any emergency visits or hospitalizations due to recurrence of AF/AFL/AT during the entire study period. Importantly, the arrhythmia must be documented by ECG (12-lead ECG or other ECG tracing obtained by emergency medical services). Emergency visits due to palpitations without an ECG-documented arrhythmia will not be considered an endpoint.
Quality of life
Quality of life: quality of life will be assessed using the standardized AFEQT (Atrial Fibrillation Effect on QualiTy-of-life) questionnaire at the baseline visit and at the 12-month follow-up visit after randomization. The 12-month score is the endpoint and is analysed with the baseline score as a covariate.
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
Institute for Clinical and Experimental Medicine
Collaborator
University Hospital Olomouc
Collaborator
Cardiocenter Podlesí, Trinec, Czech Republic
Collaborator
Faculty Hospital Kralovske Vinohrady
Collaborator
