Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT07453940

Left Atrial Appendage Closure With Versus Without Pulsed Field Ablation in Atrial Fibrillation Patients With Mild Symptoms and High Stroke Risk

Led by Sir Run Run Shaw Hospital · Updated on 2026-03-24

50

Participants Needed

1

Research Sites

43 weeks

Total Duration

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AI-Summary

What this Trial Is About

This study is a prospective, multicenter, single-blinded, randomized controlled trial to investigate whether concomitant left atrial appendage closure (LAAC) and pulsed field ablation (PFA) is more effective than LAAC alone in improving the outcomes in persistent atrial fibrillation (AF) patients with high risk of stroke. Emerging data show that some-especially those with persistent AF, high AF burden, or early atrial re-modelling-have high stroke and heart failure risks. This pilot study aims to assess whether combining LAAC and PFA improves outcomes more than LAAC alone in persistent AF patients at high stroke risk. Fifty participants will be randomly assigned in a 1:1 ratio to the LAAC or LAAC plus PFA group, with group allocation blinded. Baseline assessments included cardiopulmonary exercise testing (CPET), the Atrial Fibrillation Effect on QualiTy-of-life questionnaire (AFEQT) , and brain magnetic resonance imaging (MRI). In the LAAC group, patients will undergo electrical cardioversion followed by LAAC under general anesthesia; if sinus rhythm could not be achieved by the end of procedure, pharmocol cardioversion will be tried to restore it. In the LAAC plus PFA group, pulmonary vein isolation (PVI) and posterior wall isolation (PWI) will be performed using the FARAPULSE system, then LAAC will be done. If sinus rhythm could not be restored after PFA, cardioversion will be performed. Additional ablation is allowed only if a clear arrhythmia mechanism is identified; empirical ablation is prohibited. Follow-up occurs every two months with 7-day Holter monitoring. CPET, AFEQT, and brain MRI will be repeated at 6 months. During the blanking period, antiarrhythmic drugs may be used except amiodarone due to its long half-life. Ablation is not recommended within the first two months. Crossover to ablation is permitted only for patients with documented AF/AFL/AT recurrence and worsened symptoms (AFEQT score drop ≥10 points from baseline). At crossover or redo-ablation, AFEQT, CPET, and brain MRI will be repeated.

CONDITIONS

Official Title

Left Atrial Appendage Closure With Versus Without Pulsed Field Ablation in Atrial Fibrillation Patients With Mild Symptoms and High Stroke Risk

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 18 years or older
  • Diagnosed with persistent atrial fibrillation lasting more than 3 months
  • Atrial Fibrillation Effect on Quality-of-Life (AFEQT) score greater than 70
  • CHA2DS2-VA score of 2 or higher
  • Willing and able to give informed consent and participate in all study tests
Not Eligible

You will not qualify if you...

  • Atrial fibrillation caused by reversible or non-cardiac conditions like electrolyte imbalance, thyroid disease, or alcohol
  • History of atrial fibrillation ablation, surgical closure or exclusion of the left atrial appendage, or unsuitable left atrial appendage anatomy for closure device
  • Left atrial anteroposterior diameter of 5.5 cm or greater
  • Heart failure classified as NYHA III or IV and/or left ventricular ejection fraction 35% or less within 3 months before procedure
  • Recent (within 90 days) serious cardiac events such as myocardial infarction, unstable angina, coronary intervention, cardiac surgery, pericarditis, symptomatic pericardial effusion, gastrointestinal bleeding, stroke, transient ischemic attack, intracranial bleeding, or thromboembolic events
  • Contraindications or unwillingness to use systemic anticoagulation
  • Inability to tolerate electrophysiology procedures, general anesthesia, or study tests like CPET or MRI
  • Inability to stop Class I or III antiarrhythmic drugs except for atrial arrhythmia
  • Women who are pregnant or breastfeeding
  • Renal insufficiency with eGFR less than 30 mL/min/1.73 m2 or history of dialysis or renal transplant
  • Life expectancy less than 12 months

AI-Screening

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Trial Site Locations

Total: 1 location

1

Sir Run Run Shaw Hospital

Hangzhou, Zhejiang, China, 310000

Actively Recruiting

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Research Team

C

Chenyang Jiang

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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