Testing added heart lining ablation for persistent atrial fibrillation
Compares extra ablation lines with standard vein isolation in people with persistent atrial fibrillation.
Plain-language title generated from the registry record
Registry title: Extended Ablation Versus Pulmonary Vein Isolation to Treat Persistent Atrial Fibrillation
Key facts
- Where
- Olomouc and Prague, CzechiaSee the 4 sites
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 80 years old?
Source: NCT07424326, who can take part
Where in Czechia
- University Hospital OlomoucOlomouc, CzechiaTaking people
- Cardiocenter, 3rd Medical School, Charles University and University Hospital Kralovske VinohradyPrague, CzechiaTaking people
- IKEMPrague, CzechiaTaking people
- University Hospital Kralovske VinohradyPrague, CzechiaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Charles University, Czech Republic
- Trial code
- NCT07424326
- Record updated
- 24 September 2026
- Original 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.Read full original descriptionShow less
Extended Ablation Versus Pulmonary Vein Isolation to Treat Persistent Atrial Fibrillation
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.
Inclusion: symptomatic persistent AF; ≥1 episode of persistent AF in the last 12 months; signed informed consent.
Exclusion: any previous LA ablation; severe valvular disease (mitral valve insufficiency ≥3+, moderate or severe aortic stenosis) or history of valvular surgery or intervention; pulmonary hypertension (estimated systolic pulmonary artery pressure ≥40 mm Hg); symptomatic coronary artery disease; chronic kidney disease stage 3b or higher; left ventricular ejection fraction ≤40%; age ≥80 years; life expectancy <2 years due to other comorbidities; 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); pregnancy; LA anteroposterior diameter ≥55 mm; body mass index ≥40 kg/m2; contraindication to anticoagulation; general contraindications of catheter ablation.