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NCT Number: NCT07453940

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

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.

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Key information

Conditions

ATRIAL APPENDAGE CLOSURE for ATRIAL FIBRILLATION PFA Ablation and LAAC Procedures

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Sir Run Run Shaw Hospital

Hangzhou, Zhejiang, 310000, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age ≥ 18 years old.
  • Subjects diagnosed with persistent AF with duration more than 3 months.
  • Subjects with AFEQT score >70 .
  • Subjects with CHA2DS2-VA score ≥2.
  • Subjects who are willing and capable of providing ICF and participating in all testing associated with this study.

Exclusion criteria

  • AF that is secondary to electrolyte imbalance, thyroid disease, alcohol, or other reversible/non-cardiac causes.
  • Subjects with the history of AF ablation, LAA surgically closed or otherwise excluded or the LAA anatomy does not accommodate a Closure Device.
  • Left atrial anteroposterior diameter ≥ 5.5 cm.
  • Heart failure with a NYHA III/IV and/or LVEF ≤35% within 3 months prior to the procedure.
  • Any of the following events within 90 days of the Consent Date:
  • Myocardial infarction, unstable angina or coronary intervention or any cardiac surgery
  • Pericarditis or symptomatic pericardial effusion
  • Gastrointestinal bleeding
  • Stroke, TIA, or intracranial bleeding or any non-neurologic thromboembolic event
  • Contraindication to, or unwillingness to use systemic anticoagulation.
  • Subjects with contraindications or not tolerate to EP procedure, general anaesthesia, or the tests included in the study, like CPET, MRI.
  • Subjects cannot be removed from Class I/III AAD for reasons other than atrial arrhythmia.
  • Women of childbearing potential who are pregnant or lactating.
  • Renal insufficiency if an eGFR is < 30 mL/min/1.73 m2, or with any history of renal dialysis or renal transplant.
  • Predicted life expectancy is less than 12 months.

Treatment and study plan

LAAC plus PFA for persistent AF with high risk of stroke

Procedure

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.

LAAC for persistent AF with high risk of stroke

Procedure

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.

Primary outcomes

  1. Change in peak VO₂ from baseline to 6 months as assessed by CPET

    Time frame: 6 months

    Change in peak oxygen uptake (peak VO₂) measured by cardiopulmonary exercise testing (CPET) at the 6-month visit compared with baseline.

Secondary outcomes

  1. The change of AFEQT at 6-month visit compared to baseline.

    Time frame: 6 months

    The change of Atrial Fibrillation Effect on QualiTy-of-life questionnaire (AFEQT) at 6-month visit compared to baseline, range: 0-100; higher scores indicate better quality of life

  2. Symptomatic AF recurrence at 6 month visit after blanking period.

    Time frame: 6 months

  3. The change in CBF over 6 months.

    Time frame: 6 months

    Change in cerebral blood flow (CBF) from baseline to 6 months as assessed by arterial spin labeling brain magnetic resonance imaging (MRI)

  4. The incidence of composite clinical events

    Time frame: 6 MONTHS

    The incidence of composite clinical events, including death from cardiovascular causes, stroke (either ischemic or hemorrhagic), major bleeding or hospitalization with worsening of heart failure (unplanned hospitalization and/or intravenous use of diuretics) or acute coronary syndrome.

  5. AF burden determined by 7 d Holter during the follow-up visits.

    Time frame: 6 MONTHS

  6. Echocardiology parameters

    Time frame: 6 MONTHS

    LVEF, LA diameter, left atrial strain (LASr, LASct, LASI)

  7. Cognitive function: MoCA scale

    Time frame: 6 MONTHS

    Change in Montreal Cognitive Assessment (MoCA) total score from baseline to 6 months, MoCA total score ranges from 0 to 30, with higher scores indicating better cognitive function. The outcome will be summarized as the mean change (6-month minus baseline).

Other outcomes

  1. Actionable AF recurrence rate at 6 months, defined as occurrence of any cardioversion, ablation or AAD treatment for AF post blanking period.

    Time frame: 6 MONTHS

  2. The change of Clinical Frailty Scale Health.

    Time frame: 6 MONTHS

    The Clinical Frailty Scale (CFS) ranges from 1 to 9, with higher scores indicating worse frailty. The outcome will be summarized as the mean change (6-month minus baseline).

  3. The change of NT-proBNP/BNP at 6 month compared to baseline.

    Time frame: 6 MONTHS

  4. the imaging assessment

    Time frame: 6 months

    Baseline and 6-month multimodal brain MRI, including three-dimensional T1-weighted imaging (3D T1), T2 fluid-attenuated inversion recovery (T2-FLAIR), with optional diffusion tensor imaging (DTI). DTI is an exploratory imaging endpoint.

Sponsors and collaborators

Lead sponsor

Sir Run Run Shaw Hospital

Other

Registry information

Official study title

Left Atrial Appendage Closure and Pulsed Field Ablation Procedure Versus Left Atrial Appendage Closure Alone in Persistent Atrial Fibrillation Patients With Mild Symptoms and High Risk of Stroke: A Prospective, Multicenter, Single-Blind, Randomized Controlled Pilot Study

Acronym: REVERSE-OPTION

Important dates

Study start
2026
Primary completion
2026
Study completion
2027
First posted
Mar 6, 2026
Registry last updated
Jul 1, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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