PFA - PV + SVCI: Catheter ablation procedure using a Pulsed Field Ablation system to achieve electrical isolation of all four pulmonary veins AND the superior vena cava.
PFA - PVI only: 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.
Study summary
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.
Eligibility
Sex
ALL
Min age
18 Years
Max age
80 Years
Healthy volunteers
No
Inclusion Criteria:
1. Documented paroxysmal AF (episodes self-terminating within 7 days), evidenced by ECG, Holter, or event monitor
2. Age between 18 and 80 years
3. Willing and able to provide written informed consent
Exclusion Criteria:
1. Intracardiac thrombus (left atrium or left atrial appendage)
2. Left atrial anterior-posterior diameter \> 60 mm
3. Absolute contraindication to anticoagulation therapy
4. Stroke or myocardial infarction within 1 month prior to enrollment
5. Uncontrolled hyperthyroidism
6. Pregnancy or planning pregnancy
7. Life expectancy less than 1 year
8. Previous atrial fibrillation ablation procedure
9. Known or suspected AF triggers primarily originating from the SVC (based on pre-procedure mapping, if available)
10. Inability or unwillingness to participate in the study or comply with follow-up requirements
Primary outcome measure(s)
Freedom from atrial arrhythmia recurrence at 12 Months — 12 month 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.
Trial sites (1)
Facility
City
Region
Status
The First Affiliated Hospital of Naval Medical University (Shanghai Changhai Hospital). No. 168, Changhai Road, Yangpu District, Shanghai, China.
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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