Atrial Fibrillation; Paroxysmal Atrial Fibrillation; Persistent Atrial FibrillationNCT07902739
Pulsed Field Ablation of Atrial Fibrillation: CENTAURI Versus FARAPULSE
A study testing CENTAURI PEF system and FARAPULSE system in people with Atrial Fibrillation; Paroxysmal Atrial Fibrillation; Persistent Atrial Fibrillation, run by St. Anne's University Hospital Brno, Czech Republic at 1 site in Czechia.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atrial Fibrillation; Paroxysmal Atrial Fibrillation; Persistent Atrial Fibrillation
- What is being tested?
- CENTAURI PEF system and FARAPULSE system
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 325 participants
- Where
- 1 siteCzechia
- Study dates
- 17 May 2024to 5 Oct 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Inclusion Criteria:Age ≥18 years Symptomatic atrial fibrillation Failure, intolerance or contraindication 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 informed consent -
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; LVEF <35 %; NYHA class III-IV or uncontrolled heart failure BMI >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 Life expectancy <12 months or other condition deemed prohibitive by the investigator
-
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prospective Randomized Clinical Comparison of Catheter Ablation of Atrial Fibrillation Using the CENTAURI PEF System and the FARAPULSE System
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.
Read the detailed description
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.
- Being tested
- CENTAURI PEF system, FARAPULSE system
- Keywords
- pulsed field ablation, catheter ablation, pulmonary vein isolation, electroporation
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CENTAURI PEF systemDevice
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.
FARAPULSE systemDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| CENTAURI PEF | Active comparator | 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. Receives: Device: CENTAURI PEF system |
| FARAPULSE | Active comparator | Intervention: Device, "FARAPULSE system": single-shot pulsed field ablation using a pentaspline catheter guided by fluoroscopy and intracardiac echocardiography. Receives: Device: FARAPULSE system |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3 to 12 months after ablation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2026
- Study start17 May 2024
- Primary completion5 Oct 2026
- Study completion5 Oct 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atrial Fibrillation; Paroxysmal Atrial Fibrillation; Persistent Atrial FibrillationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 325 participants (actual)
Sponsor and investigators
- Lead sponsor
- St. Anne's University Hospital Brno, Czech Republic
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07902739
- Sponsor's protocol ID
- 41477267-2024
- Status last verified
- Oct 2026
- First submitted
- 21 Oct 2026
- Last updated
- 29 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Randomized Clinical Comparison of Catheter Ablation of Atrial Fibrillation Using the CENTAURI PEF System and the FARAPULSE System
- ClinicalTrials.gov ID
- NCT07902739
- Acronym / sponsor ID
- 41477267-2024
- Keywords
- pulsed field ablation, catheter ablation, pulmonary vein isolation, electroporation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 325 participants (actual)
- Lead sponsor
- St. Anne's University Hospital Brno, Czech RepublicUniversity, hospital or other
- Study start
- 17 May 2024 (actual)
- Primary completion
- 5 Oct 2026 (actual)
- Study completion
- 5 Oct 2026 (actual)
- First posted
- 29 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CENTAURI PEF | Active comparator | Device: CENTAURI PEF systemArm 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. |
| FARAPULSE | Active comparator | Device: FARAPULSE systemIntervention: Device, "FARAPULSE system": single-shot pulsed field ablation using a pentaspline catheter guided by fluoroscopy and intracardiac echocardiography. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CENTAURI PEF systemPoint-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. | Device | CENTAURI PEF |
| FARAPULSE systemSingle-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. | Device | FARAPULSE |
Primary outcome
Freedom from atrial arrhythmia recurrence
Time frame: 3 to 12 months after ablation
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Oct 2026.
- Individual participant dataSharing planned: No
Related trials for Atrial Fibrillation; Paroxysmal Atrial Fibrillation; Persistent Atrial Fibrillation
Recruiting
A Study Assessing Arrhythmia Mapping With a Multi-Electrode Mapping Catheter
Scar-related Atrial Tachycardia, Persistent Atrial Fibrillation
Active, not recruiting
A Study of VARIPULSE Catheter and TRUPULSE Generator With VARIPULSE Pro Software in Participants With PAF or PsAF
Atrial Fibrillation
Not yet recruiting
A Study to Predict Atrial Fibrillation (AF) Burden in Participants With PAF and PsAF Treated With the VARIPULSE™ PFA Catheter
Atrial Fibrillation
Active, not recruiting
VOLT CE Mark Study
Atrial Arrhythmia, Atrial Fibrillation
Recruiting
Comprehensive LEFt Atrial Appendage Occlusion With Rhythm Restoration
Atrial Fibrillation (AF), Paroxysmal AF
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CENTAURI PEF system and FARAPULSE system in people with Atrial Fibrillation; Paroxysmal Atrial Fibrillation; Persistent Atrial Fibrillation, run by St. Anne's University Hospital Brno, Czech Republic at 1 site in Czechia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Czechia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Freedom from atrial arrhythmia recurrence (time frame: 3 to 12 months after ablation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Oct 2026.