Adds scar-targeted heart ablation to pulmonary vein isolation for persistent atrial fibrillation
Tests added scar-targeted heart ablation with vein isolation in adults with persistent atrial fibrillation.
Plain-language title generated from the registry record
Registry title: Unipolar Voltage-Guided Substrate Modification Plus Pulsed Field Ablation Pulmonary Vein Isolation Versus Pulmonary Vein Isolation Alone in Persistent Atrial Fibrillation
Key facts
- Where
- Beijing, ChinaSee the site
Where in China
- Fuwai Hospital Chinese Academy of Medical SciencesBeijing, ChinaNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- China National Center for Cardiovascular Diseases
- Trial code
- NCT07926854
- Record updated
- 9 November 2026
- Original description
UNI-PFA is a multicenter, randomized, open-label, superiority trial evaluating whether adding unipolar voltage-guided individualized substrate modification to pulsed field ablation (PFA)-based pulmonary vein isolation (PVI) improves outcomes in patients with persistent atrial fibrillation and a left atrial low-voltage area (LVA) burden of at least 10% of the post-PVI left atrial surface area. Participants are randomized 1:1 to PFA-PVI plus individualized substrate modification (homogenization, box isolation, linear ablation, or a combination) or PFA-PVI alone. The primary endpoint is treatment success at 12 months, defined as freedom from documented atrial fibrillation, atrial tachycardia, or atrial flutter lasting more than 30 seconds after a 90-day blanking period while off class I/III antiarrhythmic drugs. Follow-up includes 14-day continuous ECG patch monitoring at 3, 6, and 12 months, symptom-triggered single-lead ECG, and quality-of-life assessments.Read full original descriptionShow less
Unipolar Voltage-Guided Individualized Substrate Modification Combined With Pulsed Field Ablation-Based Pulmonary Vein Isolation Versus Pulmonary Vein Isolation Alone in Persistent Atrial Fibrillation: A Multicenter, Randomized, Open-Label, Superiority Trial
UNI-PFA is a multicenter, randomized, open-label, superiority trial evaluating whether adding unipolar voltage-guided individualized substrate modification to pulsed field ablation (PFA)-based pulmonary vein isolation (PVI) improves outcomes in patients with persistent atrial fibrillation and a left atrial low-voltage area (LVA) burden of at least 10% of the post-PVI left atrial surface area. Participants are randomized 1:1 to PFA-PVI plus individualized substrate modification (homogenization, box isolation, linear ablation, or a combination) or PFA-PVI alone. The primary endpoint is treatment success at 12 months, defined as freedom from documented atrial fibrillation, atrial tachycardia, or atrial flutter lasting more than 30 seconds after a 90-day blanking period while off class I/III antiarrhythmic drugs. Follow-up includes 14-day continuous ECG patch monitoring at 3, 6, and 12 months, symptom-triggered single-lead ECG, and quality-of-life assessments.
Inclusion: ECG-documented persistent or long-standing persistent atrial fibrillation (ESC definition); Symptoms (palpitations, dyspnea, fatigue, etc.) attributable to atrial fibrillation; Suitable for catheter ablation; At least one class I/III antiarrhythmic drug has been tried, or the patient is unwilling to try; Age 18 years or older; Intraoperative left atrial voltage mapping demonstrating a unipolar low-voltage area (cutoff 2.5 mV) of at least 10% of the post-PVI left atrial surface area (excluding the pulmonary vein antra, left atrial appendage, and fossa ovalis).
Exclusion: Prior surgical or percutaneous atrial fibrillation ablation, or atrioventricular node ablation; Prior left atrial surgery; Acute coronary syndrome or coronary artery bypass grafting within 12 weeks; Severe aortic or mitral valve disease (ESC definition); Congenital heart disease; NYHA class IV heart failure symptoms; Dialysis-dependent renal failure; History of poor treatment adherence; Left atrial diameter >55 mm on echocardiography; Comorbidity with expected survival <1 year; Contraindication to oral anticoagulation; Atrial fibrillation due to reversible causes; Pregnancy or women of childbearing potential not using contraception; Unable or unwilling to provide informed consent.