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Not yet recruiting NCT07191626

Pulsed Field Ablation of SVC and PV in Paroxysmal Atrial Fibrillation (PASPA Study)

No phase Interventional Paroxysmal Atrial Fibrillation Paroxysmal Atrial Fibrillation (PAF)

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: PFA - PV + SVCI, PFA - PVI only.
Who it may be relevant to
Registry conditions: Paroxysmal Atrial Fibrillation, Paroxysmal Atrial Fibrillation (PAF). Basic parameters: 18 years — 80 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

Pulsed Field Ablation of Superior Vena Cava in Addition to Pulmonary Vein in Paroxysmal Atrial Fibrillation: A Multicenter Randomized Controlled Trial (PASPA Study)

Overview

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.

Detailed description

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.

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.

Primary outcome measures

  • Freedom from atrial arrhythmia recurrence at 12 Months [Time frame: 12 month]
Secondary outcome measures (1)
  • Atrial Fibrillation Burden [Time frame: 12 month]

Eligibility criteria

Inclusion criteria

  • Documented paroxysmal AF (episodes self-terminating within 7 days), evidenced by ECG, Holter, or event monitor
  • Age between 18 and 80 years
  • Willing and able to provide written informed consent

Exclusion criteria

  • Intracardiac thrombus (left atrium or left atrial appendage)
  • Left atrial anterior-posterior diameter > 60 mm
  • Absolute contraindication to anticoagulation therapy
  • Stroke or myocardial infarction within 1 month prior to enrollment
  • Uncontrolled hyperthyroidism
  • Pregnancy or planning pregnancy
  • Life expectancy less than 1 year
  • Previous atrial fibrillation ablation procedure
  • Known or suspected AF triggers primarily originating from the SVC (based on pre-procedure mapping, if available)
  • Inability or unwillingness to participate in the study or comply with follow-up requirements

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Double blind
Primary purpose
Treatment

Study locations

China · 1 center
  • The First Affiliated Hospital of Naval Medical University (Shanghai Changhai Hospital). No — Shanghai

Identifiers

NCT: NCT07191626 · PASPA-2025-001

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗