Unipolar Voltage-Guided Substrate Modification Plus Pulsed Field Ablation Pulmonary Vein Isolation Versus Pulmonary Vein Isolation Alone in Persistent Atrial Fibrillation

Brief summary (registry, in English)

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.

What you commit to

• Study type: Interventional
• Planned participants: 294
• From Nov 2026 to the primary completion date, Dec 2028
• 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 design.

AI-kivonat: who the study is looking for

Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults with persistent atrial fibrillation who have symptoms and a large area of low-voltage heart tissue found during a mapping procedure. It compares standard ablation with ablation plus extra treatment of the diseased tissue.

Age

18 years or older

Sex

All sexes can join.

Disease stage

Persistent or long-standing persistent atrial fibrillation shown on an ECG, with symptoms such as palpitations, shortness of breath or tiredness. Mapping during the procedure must show low-voltage areas of at least 10% of the left atrial surface after pulmonary vein isolation.

Earlier treatment

At least one rhythm-controlling drug (class I/III antiarrhythmic) has been tried, or the person does not want to try one. No earlier atrial fibrillation ablation.

Biomarker or test result

Unipolar low-voltage area (cutoff 2.5 mV) of at least 10% of the left atrial surface area after pulmonary vein isolation, found on voltage mapping.

Main reasons for not taking part

• Left atrial diameter over 55 mm on echocardiography
• Severe aortic or mitral valve disease, or congenital heart disease
• Earlier atrial fibrillation ablation or earlier left atrial surgery
• NYHA class IV heart failure symptoms or dialysis-dependent kidney failure
• Pregnancy, or childbearing potential without contraception

Read by machine on 10 Nov 2026.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Who the study is looking for

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

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