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

NCT07724899 | Recruiting

• 1 other identifier: N2026-07
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief 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)

Keywords

pulsed field ablation; atrial fibrillation

Outcome Measures

Primary Outcomes (1)

• the success rate of atrial fibrillation ablation

  it is assessed by 7-day Holter monitoring

  at 3 month

Secondary Outcomes (29)

• the success rate of atrial fibrillation ablation

  at 6 month and 12 month

• 6-min walk distance

  at 3 month, 6 month and 12 month

• red blood cell count

  at 3 month, 6 month and 12 month

• hemoglobin

  at 3 month, 6 month and 12 month

• white blood cell count

  at 3 month, 6 month and 12 month

Study Arms (2)

superior vena cava isolation plus pulmonary vein isolation

EXPERIMENTAL

Procedure: superior vena cava isolation plus pulmonary Vein isolation

pulmonary vein isolation

ACTIVE COMPARATOR

Procedure: pulmonary vein isolation

Interventions

superior vena cava isolation plus pulmonary Vein isolation PROCEDURE

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

superior vena cava isolation plus pulmonary vein isolation

pulmonary vein isolation PROCEDURE

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

pulmonary vein isolation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥ 18 years;
• Patients with documented atrial fibrillation (AF), confirmed by at least one episode of AF recorded on a 12-lead surface electrocardiogram (ECG) or ambulatory ECG monitoring within the past 12 months;
• Subjects who agree to undergo treatment for AF using a pulsed field ablation (PFA) system that is currently commercially available in China;
• Patients who have shown an inadequate response to, or intolerance of, at least one class of antiarrhythmic drug therapy;
• Subjects or their legally authorized representatives who have been informed of the nature of this study, have agreed to all terms and conditions of the study, and have provided written informed consent, and who are willing to complete all required clinical follow-up visits in accordance with the study protocol.

You may not qualify if:

• Prior surgical or catheter ablation for any type of cardiac arrhythmia;
• AF secondary to electrolyte imbalance, valvular heart disease, thyroid disease, or other reversible causes;
• Known requirement for ablation outside the pulmonary vein ostia or beyond the cavotricuspid isthmus;
• Sinus node dysfunction or other indications for permanent pacemaker implantation;
• Myocardial infarction, or prior coronary artery bypass grafting (CABG) or percutaneous coronary intervention (PCI) within the past 6 months;
• Left atrial anteroposterior diameter ≥ 50 mm;
• Evidence of left atrial or left atrial appendage thrombus confirmed by transesophageal echocardiography (TEE) or left atrial computed tomography (CT) within 24 hours prior to the procedure;
• Serum creatinine \> 2 times the upper limit of normal, or currently on dialysis;
• History of prior cardiothoracic surgery;
• History of permanent pacemaker implantation;
• History of malignancy;
• Long-term use of a central venous catheter;
• Contraindications to anticoagulation therapy (including allergy to anticoagulants, thrombocytopenia, severe bleeding tendency, or coagulation disorders);
• History of allergy to contrast;
• Women who are pregnant, lactating, or who are unwilling to use adequate contraception during the study period;

Sponsors & Collaborators

• Qiang Hu: lead

Study Sites (1)

Qiang Hu

Chengdu, Sichuan, 610000, China

RECRUITING

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Qiang Hu, Doctor

CONTACT

+8602886590223; huqiang071@foxmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 21, 2026
• First Posted: July 24, 2026
• Study Start: July 20, 2026
• Primary Completion (Estimated): March 31, 2029
• Study Completion (Estimated): March 31, 2029
• Last Updated: July 27, 2026

Record last verified: 2026-07

Locations

CN (1)