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Efficacy and Safety of Superior Vena Cava Isolation and Pulmonary Vein Isolation for Treatment of Atrial Fibrillation

NCT07724899 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 200

Last updated 2026-07-27

No results posted yet for this study

Summary

Atrial fibrillation (AF) is one of the most concerning diseases in the field of cardiac arrhythmias. It is a type of rapid supraventricular arrhythmia characterized by rapid and disorganized contraction of the atria, which leads to ventricular rate disturbance, impaired cardiac function, and an increased risk of atrial mural thrombus formation. AF severely reduces patients' quality of life and can cause complications such as heart failure, stroke, and sudden death. Currently, the vast majority of AF episodes are triggered by pulmonary vein (PV) ectopic foci. Therefore, catheter ablation is the preferred treatment strategy, with pulmonary vein isolation (PVI) being the cornerstone procedure. However, a small proportion of patients may have non-PV triggers, particularly originating from the superior vena cava (SVC). Conventional radiofrequency ablation (RFA) for SVC isolation carries unpredictable risks, including damage to the sinus node and the phrenic nerve. Therefore, this study aims to investigate the impact of empirical SVC electrical isolation in addition to PVI on the success rate of AF ablation, using pulsed field ablation (PFA)-a non-thermal ablation modality with tissue selectivity and a favorable safety profile.

Conditions

  • Atrial Fibrillation (AF)

Interventions

PROCEDURE

superior vena cava isolation plus pulmonary Vein isolation

Eligible patients with atrial fibrillation who are randomized to the experimental group will undergo superior vena cava (SVC) electrical isolation in addition to pulmonary vein isolation (PVI) during the pulsed field ablation procedure

PROCEDURE

pulmonary vein isolation

Eligible patients with atrial fibrillation who are randomized to the control group will undergo pulmonary vein isolation (PVI) during the pulsed field ablation procedure

Sponsors & Collaborators

  • Qiang Hu

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-07-20
Primary Completion
2029-03-31
Completion
2029-03-31

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 NCT07724899 on ClinicalTrials.gov