Pulsed Field Ablation of SVC and PV in Paroxysmal Atrial Fibrillation (PASPA Study)
NCT07191626 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 650
Last updated 2025-09-25
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.
Conditions
- Paroxysmal Atrial Fibrillation
- Paroxysmal Atrial Fibrillation (PAF)
Interventions
- PROCEDURE
-
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.
- PROCEDURE
-
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.
Sponsors & Collaborators
-
Changhai Hospital
lead OTHER
Principal Investigators
-
zhifu guo, MD · The First Affiliated Hospital of Naval Medical University (Shanghai Changhai Hospital)
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- DOUBLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 80 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2025-11-01
- Primary Completion
- 2027-11-01
- Completion
- 2027-11-01
Countries
- China
Study Locations
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