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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pulmonary Vein Isolation using Point-by-Point Bipolar Pulsed-Field Ablation | Procedure | Pulmonary vein isolation is performed via transseptal access to the left atrium using a point-by-point bipolar pulsed-field ablation catheter |
| Measure | Description | Time Frame |
|---|---|---|
| Recurrence of atrial fibrillation | Any symptomatic or asymptomatic episode of atrial fibrillation lasting >30 seconds, confirmed by ECG or Holter monitoring. | 12 months post-procedure |
| Measure | Description | Time Frame |
|---|---|---|
| Intraprocedural bradyarrhythmic episodes | Number of Participants with periprocedural occurrence of bradyarrhythmias lasting >10 seconds that require atropine administration or temporary pacing. | During ablation procedure |
| Requirement for intraprocedural cardioversion |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Piotr Futyma, MD, PhD | Contact | +48 17 858 19 00 | piotr.futyma@gmail.com | |
| Łukasz Zarębski, MD | Contact | +48 17 858 19 00 | lukasz.zarebski@interia.pl |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| St. Joseph's Heart Rhythm Center | Recruiting | Rzeszów | Podkarpackie Voivodeship | 35-623 | Poland |
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| Selective Radiofrequency Ablation of the Superior Paraseptal Parasympathetic Ganglion | Procedure | 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. |
|
Number of Participants with periprocedural need for electrical cardioversion to terminate atrial fibrillation episodes during the procedure. |
| During ablation procedure |
| ID | Term |
|---|---|
| D001281 | Atrial Fibrillation |
| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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