The PASPA study is a multicenter, randomized trial comparing Pulmonary Vein Isolation (PVI) alone versus PVI plus Superior Vena Cava Isolation (SVCI) using Pulsed Field Ablation (PFA) in patients with paroxysmal atrial fibrillation (PAF). 650 participants will be followed for 12 months. The main goal is to see if adding SVCI reduces arrhythmia recurrence without increasing complications such as phrenic nerve injury or sinus node dysfunction.
The PASPA study addresses the limitations of traditional pulmonary vein isolation (PVI) for paroxysmal atrial fibrillation (PAF), where recurrence rates remain significant due to non-pulmonary vein triggers such as the superior vena cava (SVC). Traditional ablation near the SVC carries risks of phrenic nerve and sinus node injury, and acute isolation success rates are only 75%-85%. Pulsed Field Ablation (PFA) selectively ablates cardiomyocytes through irreversible electroporation while sparing adjacent nerves and vessels, allowing safer SVC isolation. This prospective, multicenter, randomized controlled trial will enroll 650 patients with documented PAF, randomly assigned to PVI alone or PVI plus SVC isolation (SVCI) using PFA. Participants will be followed for 12 months with 7-day Holter monitoring at 3, 6, and 12 months. The primary endpoint is freedom from atrial fibrillation, atrial flutter, or atrial tachycardia episodes ≥30 seconds at 12 months. Secondary endpoints include atrial fibrillation burden and procedure-related complications such as phrenic nerve injury, cardiac tamponade, and sinus node dysfunction. Preliminary animal and pilot human studies indicate that PFA achieves 100% acute SVC isolation with minimal complications. The study aims to determine whether adding SVCI to PVI improves efficacy in PAF without increasing procedural risks, providing evidence to guide standardized ablation strategies.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
Catheter ablation procedure using a Pulsed Field Ablation system to achieve electrical isolation of all four pulmonary veins AND the superior vena cava.
Catheter ablation procedure using a Pulsed Field Ablation system to achieve electrical isolation of all four pulmonary veins only. No ablation is performed in the superior vena cava.
The First Affiliated Hospital of Naval Medical University (Shanghai Changhai Hospital). No. 168, Changhai Road, Yangpu District, Shanghai, China.
Shanghai, Shanghai Municipality, China
Freedom from atrial arrhythmia recurrence at 12 Months
Proportion of participants without recurrence of atrial fibrillation, atrial flutter, or atrial tachycardia lasting ≥30 seconds, as assessed by 7-day continuous ambulatory ECG monitoring, during the 12-month follow-up period after ablation.
Time frame: 12 month
Atrial Fibrillation Burden
The percentage of time spent in atrial fibrillation during the 7-day Holter monitoring periods, calculated as (total AF duration / total recording duration) \* 100%.
Time frame: 12 month
zhifu guo, MD
CONTACT
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