An interventional study of CENTAURI PEF system and FARAPULSE system in Atrial Fibrillation; Paroxysmal Atrial Fibrillation; Persistent Atrial Fibrillation, sponsored by St. Anne's University Hospital Brno, Czech Republic. Completed at 1 site in Czechia. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-29.
Sponsored by St. Anne's University Hospital Brno, Czech Republic · Not applicable, Interventional, and Treatment
The aim of this study is to compare the efficacy of two commercially available pulsed field ablation (PFA) systems for catheter ablation of atrial fibrillation. Patients are randomized 1:1 to point-by-point PFA using the CENTAURI PEF system with 3D electroanatomical mapping, or to single-shot PFA using the FARAPULSE pentaspline catheter guided by fluoroscopy and intracardiac echocardiography. The primary endpoint is freedom from documented atrial arrhythmia recurrence between 3 and 12 months after ablation.
n the CENTAURI PEF arm, the left atrium is mapped using the EnSite Precision 3D mapping system (Abbott), and PFA is delivered point-by-point using a contact-force sensing ablation catheter (TactiCath SE, Abbott) connected to the CENTAURI generator. In the FARAPULSE arm, PFA is delivered with a multielectrode pentaspline catheter navigated by fluoroscopy and intracardiac echocardiography without a 3D mapping system. All procedures are performed under general anesthesia. Pulmonary vein isolation is performed in all patients; additional ablation of low-voltage or fractionated areas is at the operator's discretion. Follow-up visits are scheduled at 3, 6, and 12 months with 12-lead ECG, 24-hour Holter monitoring at 3 and 6 months, and 7-day ECG monitoring at 12 months.
4,009 studies on the registry are indexed under Atrial Fibrillation; 961 are open to participants now.
This study's enrollment of 325 is above the median of 150 across 2,476 interventional studies indexed under Atrial Fibrillation.
Browse Atrial Fibrillation studies →St. Anne's University Hospital Brno, Czech Republic is the lead sponsor of 25 studies on the registry; 10 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Inclusion Criteria:Age ≥18 years Symptomatic atrial fibrillation Failure, intolerance or of at least one class I or III antiarrhythmic drug Suitable candidate for intracardiac mapping and ablation Willing to attend follow-up for at least 12 months Signed -
Exclusion Criteria:Continuous AF >36 months AF due to electrolyte imbalance, thyroid disease or other reversible/non-cardiac cause Rheumatic heart disease; severe mitral regurgitation; hypertrophic cardiomyopathy LA diameter >60 mm; \<35 %; class III-IV or uncontrolled heart failure >42 kg/m² Prior LA ablation, septal closure device or mitral valve surgery Intracardiac thrombus, tumor or abnormality precluding catheter access Coagulopathy or bleeding diathesis Active infection, sepsis or fever >38 °C within one week before ablation Significant restrictive or obstructive pulmonary disease Dialysis or renal impairment deemed prohibitive by the investigator Allergy/intolerance to anticoagulation, antiplatelet therapy or contrast Pregnancy or breastfeeding Participation in a concurrent study affecting results \<12 months or other condition deemed prohibitive by the investigator
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Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
LVEF (left ventricular ejection fraction)
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
NYHA class (heart failure)
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Arm 1: CENTAURI PEF, typ Active Comparator Intervention: Device, "CENTAURI PEF system": point-by-point pulsed field ablation using the CENTAURI generator with a TactiCath SE catheter and EnSite Precision 3D mapping.
Device: CENTAURI PEF system
Intervention: Device, "FARAPULSE system": single-shot pulsed field ablation using a pentaspline catheter guided by fluoroscopy and intracardiac echocardiography.
Device: FARAPULSE system
Point-by-point pulsed field ablation using the CENTAURI generator connected to a contact-force sensing focal ablation catheter (TactiCath SE, Abbott), guided by the EnSite Precision 3D electroanatomical mapping system (Abbott). Pulmonary vein isolation is performed in all patients; additional ablation of low-voltage areas is at the operator's discretion. Procedure performed under general anesthesia.
Single-shot pulsed field ablation using the FARAPULSE system (Boston Scientific) with a multielectrode pentaspline ablation catheter, guided by fluoroscopy and intracardiac echocardiography without a 3D mapping system. Pulmonary vein isolation is performed in all patients; additional ablation of low-voltage or fractionated areas is at the operator's discretion. Procedure performed under general anesthesia.
Freedom from atrial arrhythmia recurrence
Absence of documented AF, atrial flutter or atrial tachycardia lasting ≥30 seconds after the 3-month blanking period. Failure also includes: acute failure to isolate all targeted pulmonary veins, electrical cardioversion, repeat ablation, or initiation/dose escalation of antiarrhythmic drug for AF during the evaluation period.
Time frame: 3 to 12 months after ablation
Plan to share: No
No publications or documents are linked to this record.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is completed, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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St. Anne's University Hospital Brno, Czech Republic