Efficacy and Safety of Superior Vena Cava Isolation and Pulmonary Vein Isolation for Treatment of Atrial Fibrillation (SAVE-AF)

Efficacy and Safety of Superior Vena Cava Isolation in Addition to Pulmonary Vein Isolation by Pulsed Field Ablation for Treatment of Atrial Fibrillation

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.

Study Overview

• Status: Recruiting
• Conditions: Atrial Fibrillation (AF)
• Intervention / Treatment: Procedure: superior vena cava isolation plus pulmonary Vein isolation; Procedure: pulmonary vein isolation

• Study Type: Interventional
• Enrollment (Estimated): 200
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Qiang Hu, Doctor; Phone Number: +8602886590223; Email: huqiang071@foxmail.com

Study Locations

• China
  • Sichuan
    • Chengdu, Sichuan, China, 610000
      • Recruiting
      • Qiang Hu
      • Contact: Qiang Hu, Doctor; Phone Number: +8602886590223; Email: huqiang071@foxmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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;
• Subjects or their legally authorized representatives who are unwilling to provide written informed consent;
• Subjects who, for any reason, are unable to comply with the study protocol or complete all required clinical follow-up visits;
• Subjects deemed by the investigator to be unsuitable for PFA treatment of AF.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: superior vena cava isolation plus pulmonary vein isolation	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
Active Comparator: pulmonary vein isolation	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
the success rate of atrial fibrillation ablation	it is assessed by 7-day Holter monitoring	at 3 month

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
the success rate of atrial fibrillation ablation	it is assessed by 7-day Holter monitoring	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
platelet count		at 3 month, 6 month and 12 month
alanine aminotransferase		at 3 month, 6 month and 12 month
aspartate aminotransferase		at 3 month, 6 month and 12 month
creatinine		at 3 month, 6 month and 12 month
urea		at 3 month, 6 month and 12 month
estimated glomerular filtration rate		at 3 month, 6 month and 12 month
activated partial thromboplastin time		at 3 month, 6 month and 12 month
prothrombin time		at 3 month, 6 month and 12 month
international normalized ratio		at 3 month, 6 month and 12 month
B-type natriuretic peptide		at 3 month, 6 month and 12 month
left ventricular end-systolic diameter	it is measured by echocardiography	at 3 month, 6 month and 12 month
left ventricular end-diastolic diameter	it is measured by echocardiography	at 3 month, 6 month and 12 month
left ventricular posterior wall thickness	it is measured by echocardiography	at 3 month, 6 month and 12 month
interventricular septal thickness	it is measured by echocardiography	at 3 month, 6 month and 12 month
left ventricular ejection fraction	it is measured by echocardiography	at 3 month, 6 month and 12 month
E/A	it is measured by echocardiography	at 3 month, 6 month and 12 month
E/e'	it is measured by echocardiography	at 3 month, 6 month and 12 month
left atrial volume index	it is measured by echocardiography	at 3 month, 6 month and 12 month
left atrial anteroposterior diameter	it is measured by echocardiography	at 3 month, 6 month and 12 month
left atrial strain	it is measured by echocardiography	at 3 month, 6 month and 12 month
New York Heart Association class	The NYHA is measured by Classification of NYHA heart function	at 3 month, 6 month and 12 month
Atrial Fibrillation Effect on QualiTy of Life Questionnaire		at 3 month, 6 month and 12 month
Major adverse events	Major adverse events is a composite endpoint of death, stroke, and myocardial infarction.	at 3 month, 6 month and 12 month
readmission		at 3 month, 6 month and 12 month

Collaborators and Investigators

• Sponsor: Qiang Hu

Study record dates

Study Major Dates

• Study Start (Actual): July 20, 2026
• Primary Completion (Estimated): March 31, 2029
• Study Completion (Estimated): March 31, 2029

Study Registration Dates

• First Submitted: July 21, 2026
• First Submitted That Met QC Criteria: July 21, 2026
• First Posted (Actual): July 24, 2026

Study Record Updates

• Last Update Posted (Actual): July 24, 2026
• Last Update Submitted That Met QC Criteria: July 21, 2026
• Last Verified: July 1, 2026

More Information

Terms related to this study

• Keywords: atrial fibrillation; pulsed field ablation
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Pathologic Processes; Heart Diseases; Arrhythmias, Cardiac; Pathological Conditions, Signs and Symptoms; Atrial Fibrillation
• Other Study ID Numbers: N2026-07

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No