NCT07724899Recruiting
Efficacy and Safety of Superior Vena Cava Isolation and Pulmonary Vein Isolation for Treatment of Atrial Fibrillation
Efficacy and Safety of Superior Vena Cava Isolation in Addition to Pulmonary Vein Isolation by Pulsed Field Ablation for Treatment of Atrial Fibrillation
Source: ClinicalTrials.gov · Last updated 27 Jul 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 200 (estimated)
- First submitted
- 21 Jul 2026
- Start date
- Jul 2026
- Primary completion date
- Mar 2029
- Lead sponsor
- Qiang Hu
- Diseases
- Atrial fibrillation
- NCT number
- NCT07724899
What you commit to
- Study type: Interventional
- Planned participants: 200
- From Jul 2026 to the primary completion date, Mar 2029
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Prior surgical or catheter ablation for any type of cardiac arrhythmia;
- Myocardial infarction, or prior coronary artery bypass grafting (CABG) or percutaneous coronary intervention (PCI) within the past 6 months;
- 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;
- History of prior cardiothoracic surgery;
Other illness
- AF secondary to electrolyte imbalance, valvular heart disease, thyroid disease, or other reversible causes;
- History of permanent pacemaker implantation;
- History of malignancy;
- Contraindications to anticoagulation therapy (including allergy to anticoagulants, thrombocytopenia, severe bleeding tendency, or coagulation disorders);
- History of allergy to contrast;
Lab values
- Serum creatinine \> 2 times the upper limit of normal, or currently on dialysis;
Other
- Known requirement for ablation outside the pulmonary vein ostia or beyond the cavotricuspid isthmus;
- Sinus node dysfunction or other indications for permanent pacemaker implantation;
- Left atrial anteroposterior diameter ≥ 50 mm;
- Long-term use of a central venous catheter;
- 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.
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Qiang Hu Coordinator of this site? Confirm its status | Chengdu | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.