Pulsed field ablation for AF: isolated Superior Vena Cava plus Pulmonary Vein isolation

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This interventional study investigates using pulsed field ablation to achieve isolation of both the superior vena cava and the pulmonary veins in patients with atrial fibrillation. Participants are adults with confirmed AF who have not adequately benefited from at least one antiarrhythmic drug and who will undergo this catheter-based ablation procedure. The trial aims to assess the safety and effectiveness of this dual isolation strategy, which may reduce AF triggers from non-pulmonary sites while minimizing collateral injury. The study is conducted at a single center in Chengdu, China, led by investigator Qiang Hu. Enrollment and follow-up involve standard clinical assessments and rhythm monitoring to evaluate outcomes.

Why it matters

Who can join: the full rules

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.

Where it's running

• Qiang Hu
  Chengdu, Sichuan, China Recruiting

Study contacts

• Study coordinator: Qiang Hu, Doctor
• Email: huqiang071@foxmail.com
• Phone: +8602886590223

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.