Atrial Fibrillation (Paroxysmal)PFACNA-AFNCT07171463
Pulsed Field Ablation With Concomitant Radiofrequency Cardioneuroablation in Patients With Paroxysmal Atrial Fibrillation
A study testing Pulmonary Vein Isolation using Point-by-Point Bipolar Pulsed-Field Ablation and Selective Radiofrequency Ablation of the Superior Paraseptal Parasympathetic Ganglion in people with Atrial Fibrillation (Paroxysmal), run by St. Joseph's Centre, Poland at 1 site in Poland.
Trial summary
Pulsed-field ablation (PFA) is a novel, non-thermal method for the treatment of atrial fibrillation (AF). It uses short, high-voltage electrical pulses to selectively ablate cardiomyocytes. PFA has demonstrated a high safety profile with reduced complication rates compared to thermal ablation. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atrial Fibrillation (Paroxysmal)
- What is being tested?
- Pulmonary Vein Isolation using Point-by-Point Bipolar Pulsed-Field Ablation and Selective Radiofrequency Ablation of the Superior Paraseptal Parasympathetic Ganglion
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 sitePoland
- Study dates
- 26 May 2025to 30 Sep 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
Who may be able to join
- Age ≥18 years
- Documented paroxysmal atrial fibrillation (AF) lasting ≥30 seconds on ECG or Holter monitoring
- Willingness and ability to provide written informed consent
- Life expectancy >1 year
Who cannot join
- Persistent AF lasting >7 days or long-standing AF >1 year
- Secondary AF due to electrolyte imbalance, thyroid disease, alcohol abuse, or other non-cardiac causes
- Left atrial anteroposterior diameter ≥45 mm on transthoracic echocardiography
- Clinically significant coexisting arrhythmias other than AF
- Significant valvular heart disease or valve prosthesis
- Chronic heart failure NYHA class III/IV
Show all 25Show fewer
- Previous AF or atrial flutter ablation
- Prior closure of atrial septal defect or left atrial appendage
- Atrial myxoma
- Implanted pacemaker or defibrillator
- History of pericarditis
- Congenital heart disease
- Coagulopathy or bleeding disorders
- Contraindications to oral anticoagulation
- Contraindications to CT or MRI
- Pregnancy or breastfeeding
- Body Mass Index >30
- History of organ transplantation
- Severe pulmonary disease
- Estimated Glomerular Filtration Rate <30 mL/min/1.73 m²
- Active malignancy
- Significant infection
- Life expectancy <1 year
- Psychiatric disorders preventing study participation
- Refusal or inability to provide informed consent
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Poland1 site, 1 recruiting
- Recruiting
St. Joseph's Heart Rhythm Center
Rzeszów, Podkarpackie Voivodeship, 35-623
Piotr Futyma, MD, PhD, +48 533 503 044, piotr.futyma@gmail.com
Łukasz Zarębski, MD, +48 17 858 19 00, lukasz.zarebski@interia.pl
About this study
Official title: Evaluation of the Safety and Efficacy of Pulmonary Vein Isolation for Paroxysmal Atrial Fibrillation Using Point-by-Point Bipolar Pulsed Field Ablation Combined With Thermal Ablation of the Superior Paraseptal Parasympathetic Ganglion Region
Pulsed-field ablation (PFA) is a novel, non-thermal method for the treatment of atrial fibrillation (AF). It uses short, high-voltage electrical pulses to selectively ablate cardiomyocytes. PFA has demonstrated a high safety profile with reduced complication rates compared to thermal ablation.
Thermal ablation of parasympathetic ganglia during conventional pulmonary vein isolation (PVI) may improve long-term procedural outcomes by reducing AF recurrence. However, due to its non-thermal nature, PFA may not significantly affect cardiac autonomic innervation, which could be clinically relevant in vagally mediated AF or tachycardia-bradycardia syndrome.
This randomized study compares two strategies: (1) PFA-only PVI, and (2) PFA combined with selective thermal ablation (radiofrequency energy) of the superior paraseptal parasympathetic ganglion. The primary objective is to evaluate whether adjunctive thermal ablation improves clinical outcomes and reduces intraprocedural bradyarrhythmic events.
- Conditions
- Atrial Fibrillation (Paroxysmal)
- Being tested
- Pulmonary Vein Isolation using Point-by-Point Bipolar Pulsed-Field Ablation, Selective Radiofrequency Ablation of the Superior Paraseptal Parasympathetic Ganglion
- Keywords
- Atrial fibrillation, Pulsed Field Ablation, Cardioneuroablation
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pulmonary Vein Isolation using Point-by-Point Bipolar Pulsed-Field AblationProcedure or surgery
Pulmonary vein isolation is performed via transseptal access to the left atrium using a point-by-point bipolar pulsed-field ablation catheter
Selective Radiofrequency Ablation of the Superior Paraseptal Parasympathetic GanglionProcedure or surgery
Targeted application of radiofrequency energy at the anterior aspect of the right superior pulmonary vein, corresponding to the anatomical location of the superior paraseptal parasympathetic ganglion.
| Study group | Role | What they receive |
|---|---|---|
| PFA with selective thermal ganglion ablation | Experimental | Participants will undergo pulmonary vein isolation using a point-by-point bipolar pulsed-field ablation. In addition, selective thermal ablation using radiofrequency energy will be performed at the anterior aspect of the right superior pulmonary vein, corresponding to the anatomical region of the superior paraseptal parasympathetic ganglion. Receives: Procedure: Pulmonary Vein Isolation using Point-by-Point Bipolar Pulsed-Field Ablation; Procedure: Selective Radiofrequency Ablation of the Superior Paraseptal Parasympathetic Ganglion |
| Standard PFA pulmonary vein isolation | Active comparator | Participants will undergo pulmonary vein isolation using the same point-by-point bipolar PFA system without any additional thermal applications. Receives: Procedure: Pulmonary Vein Isolation using Point-by-Point Bipolar Pulsed-Field Ablation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recurrence of atrial fibrillation
Any symptomatic or asymptomatic episode of atrial fibrillation lasting >30 seconds, confirmed by ECG or Holter monitoring.
Measured: 12 months post-procedure
Secondary outcomes (2)
Intraprocedural bradyarrhythmic episodes
Number of Participants with periprocedural occurrence of bradyarrhythmias lasting >10 seconds that require atropine administration or temporary pacing.
Measured: During ablation procedure
Requirement for intraprocedural cardioversion
Number of Participants with periprocedural need for electrical cardioversion to terminate atrial fibrillation episodes during the procedure.
Measured: During ablation procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2025
- Study start26 May 2025
- Primary completion30 Sep 2025 (estimated)
- Study completion30 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atrial Fibrillation (Paroxysmal)Studies 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- St. Joseph's Centre, Poland
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Łukasz Zarębski, St. Joseph's Centre, Poland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07171463
- Sponsor's protocol ID
- 12/2025/B
- Acronym
- PFACNA-AF
- Status last verified
- Sep 2025
- First submitted
- 29 Aug 2025
- Last updated
- 12 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Safety and Efficacy of Pulmonary Vein Isolation for Paroxysmal Atrial Fibrillation Using Point-by-Point Bipolar Pulsed Field Ablation Combined With Thermal Ablation of the Superior Paraseptal Parasympathetic Ganglion Region
- ClinicalTrials.gov ID
- NCT07171463
- Acronym / sponsor ID
- PFACNA-AF / 12/2025/B
- Conditions
- Atrial Fibrillation (Paroxysmal)
- Keywords
- Atrial fibrillation, Pulsed Field Ablation, Cardioneuroablation
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- St. Joseph's Centre, PolandUniversity, hospital or other
- Study start
- 26 May 2025 (actual)
- Primary completion
- 30 Sep 2025 (estimated)
- Study completion
- 30 Sep 2026 (estimated)
- First posted
- 12 Sep 2025 (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.
Pulsed-field ablation (PFA) is a novel, non-thermal method for the treatment of atrial fibrillation (AF). It uses short, high-voltage electrical pulses to selectively ablate cardiomyocytes. PFA has demonstrated a high safety profile with reduced complication rates compared to thermal ablation.
Thermal ablation of parasympathetic ganglia during conventional pulmonary vein isolation (PVI) may improve long-term procedural outcomes by reducing AF recurrence. However, due to its non-thermal nature, PFA may not significantly affect cardiac autonomic innervation, which could be clinically relevant in vagally mediated AF or tachycardia-bradycardia syndrome.
This randomized study compares two strategies: (1) PFA-only PVI, and (2) PFA combined with selective thermal ablation (radiofrequency energy) of the superior paraseptal parasympathetic ganglion. The primary objective is to evaluate whether adjunctive thermal ablation improves clinical outcomes and reduces intraprocedural bradyarrhythmic events.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PFA with selective thermal ganglion ablation | Experimental | Procedure: Pulmonary Vein Isolation using Point-by-Point Bipolar Pulsed-Field Ablation, Procedure: Selective Radiofrequency Ablation of the Superior Paraseptal Parasympathetic GanglionParticipants will undergo pulmonary vein isolation using a point-by-point bipolar pulsed-field ablation. In addition, selective thermal ablation using radiofrequency energy will be performed at the anterior aspect of the right superior pulmonary vein, corresponding to the anatomical region of the superior paraseptal parasympathetic ganglion. |
| Standard PFA pulmonary vein isolation | Active comparator | Procedure: Pulmonary Vein Isolation using Point-by-Point Bipolar Pulsed-Field AblationParticipants will undergo pulmonary vein isolation using the same point-by-point bipolar PFA system without any additional thermal applications. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age ≥18 years
- Documented paroxysmal atrial fibrillation (AF) lasting ≥30 seconds on ECG or Holter monitoring
- Willingness and ability to provide written informed consent
- Life expectancy >1 year
Key exclusion criteria (25 listed)
- Persistent AF lasting >7 days or long-standing AF >1 year
- Secondary AF due to electrolyte imbalance, thyroid disease, alcohol abuse, or other non-cardiac causes
- Left atrial anteroposterior diameter ≥45 mm on transthoracic echocardiography
- Clinically significant coexisting arrhythmias other than AF
- Significant valvular heart disease or valve prosthesis
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 |
|---|---|---|
| Pulmonary Vein Isolation using Point-by-Point Bipolar Pulsed-Field AblationPulmonary vein isolation is performed via transseptal access to the left atrium using a point-by-point bipolar pulsed-field ablation catheter | Procedure or surgery | PFA with selective thermal ganglion ablation, Standard PFA pulmonary vein isolation |
| Selective Radiofrequency Ablation of the Superior Paraseptal Parasympathetic GanglionTargeted application of radiofrequency energy at the anterior aspect of the right superior pulmonary vein, corresponding to the anatomical location of the superior paraseptal parasympathetic ganglion. | Procedure or surgery | PFA with selective thermal ganglion ablation |
Primary outcome
Recurrence of atrial fibrillation
Time frame: 12 months post-procedure
Any symptomatic or asymptomatic episode of atrial fibrillation lasting >30 seconds, confirmed by ECG or Holter monitoring.
2 secondary outcomes
Intraprocedural bradyarrhythmic episodes
Time frame: During ablation procedure
Requirement for intraprocedural cardioversion
Time frame: During ablation procedure
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Sep 2025.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pulmonary Vein Isolation using Point-by-Point Bipolar Pulsed-Field Ablation and Selective Radiofrequency Ablation of the Superior Paraseptal Parasympathetic Ganglion in people with Atrial Fibrillation (Paroxysmal), run by St. Joseph's Centre, Poland at 1 site in Poland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 25 exclusion criteria. 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: looking for participants now, as of the sponsor's last update on 12 Sep 2025. 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 Poland. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Piotr Futyma, MD, PhD (+48 17 858 19 00, piotr.futyma@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recurrence of atrial fibrillation (time frame: 12 months post-procedure). 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 12 Sep 2025; AzTrials last refreshed its copy on 8 Nov 2026.