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

No results posted yet for this 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.

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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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07191626 on ClinicalTrials.gov