ATRIAL APPENDAGE CLOSURE for ATRIAL FIBRILLATIONREVERSE-OPTIONNCT07453940
Left Atrial Appendage Closure With Versus Without Pulsed Field Ablation in Atrial Fibrillation Patients With Mild Symptoms and High Stroke Risk
A study testing LAAC plus PFA for persistent AF with high risk of stroke and LAAC for persistent AF with high risk of stroke in people with ATRIAL APPENDAGE CLOSURE for ATRIAL FIBRILLATION and PFA Ablation and LAAC Procedures, run by Sir Run Run Shaw Hospital at 1 site in China.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- ATRIAL APPENDAGE CLOSURE for ATRIAL FIBRILLATION, PFA Ablation and LAAC Procedures
- What is being tested?
- LAAC plus PFA for persistent AF with high risk of stroke and LAAC for persistent AF with high risk of stroke
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteChina
- Study dates
- 7 May 2026to 31 Jan 2027
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official 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
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.
- Being tested
- LAAC plus PFA for persistent AF with high risk of stroke, LAAC for persistent AF with high risk of stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LAAC plus PFA for persistent AF with high risk of strokeProcedure or surgery
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 strokeProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| LAAC+PFA group | Experimental | LAAC plus PFA Receives: Procedure: LAAC plus PFA for persistent AF with high risk of stroke |
| LAAC group | Active comparator | LAAC alone Receives: Procedure: LAAC for persistent AF with high risk of stroke |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in peak VO₂ from baseline to 6 months as assessed by CPET
Change in peak oxygen uptake (peak VO₂) measured by cardiopulmonary exercise testing (CPET) at the 6-month visit compared with baseline.
Measured: 6 months
Secondary outcomes (7)
The change of AFEQT at 6-month visit compared to baseline.
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
Measured: 6 months
Symptomatic AF recurrence at 6 month visit after blanking period.
Measured: 6 months
The change in CBF over 6 months.
Change in cerebral blood flow (CBF) from baseline to 6 months as assessed by arterial spin labeling brain magnetic resonance imaging (MRI)
Measured: 6 months
The incidence of composite clinical events
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.
Measured: 6 MONTHS
AF burden determined by 7 d Holter during the follow-up visits.
Measured: 6 MONTHS
Echocardiology parameters
LVEF, LA diameter, left atrial strain (LASr, LASct, LASI)
Measured: 6 MONTHS
Cognitive function: MoCA scale
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).
Measured: 6 MONTHS
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2026
- Study start7 May 2026
- Primary completion15 Dec 2026 (estimated)
- Study completion31 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ATRIAL APPENDAGE CLOSURE for ATRIAL FIBRILLATIONStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sir Run Run Shaw Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chenyang Jiang, Sir Run Run Shaw Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07453940
- Sponsor's protocol ID
- SRRSH-ER-2026-Research-0108
- Acronym
- REVERSE-OPTION
- Status last verified
- May 2026
- First submitted
- 27 Jan 2026
- Last updated
- 1 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No