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Extended Ablation Versus Pulmonary Vein Isolation to Treat Persistent Atrial Fibrillation

RecruitingNAAges 18 Years - 80 YearsAllCharles University, Czech Republic
NCT07424326 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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

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📋 Eligibility rules (as published)
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
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What it tests

  • PVI-plus
  • PVI-only
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Where

4 sites
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
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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