One procedure, two goals: Pulsed-Field ablation plus LAA occlusion tested for AF
NCT ID NCT05560204
First seen Sep 16, 2026 · Last updated Sep 17, 2026 · Updated 1 time
Summary
Researchers are testing whether combining pulsed-field ablation with left atrial appendage occlusion in a single procedure can control atrial fibrillation and prevent stroke. The trial enrolls 200 adults with non-valvular atrial fibrillation and a higher stroke risk. Participants receive both treatments using either the Watchman Flx or Amulet device, and researchers compare procedural outcomes and leak rates around the device.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- pulsed-field ablation combined with left atrial appendage occlusion using Watchman Flx or Amulet devices
- What this could lead to
- If successful, this could offer patients with atrial fibrillation a single procedure that controls heart rhythm and lowers stroke risk without long-term blood thinners.
- What could go wrong
- This is an early randomized study of 200 people, so it may not show clear differences between the two devices. Combining procedures carries risks like bleeding, stroke, or device complications.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 200 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jan 2023
- Expected to finish
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Dec 2027
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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19 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Paroxysmal or persistent non- valvular atrial fibrillation 2. CHADS2-VASc \>=2 3. Age \>=18; and able to give written consent Exclusion Criteria: 1. are in permanent atrial fibrillation 2. are not eligible for 3 months of oral anticoagulant post ablation 3. has left Atrial thrombus identified by pre-procedure TEE or during procedure 4. had received prior left atrial appendage closure procedure (percutaneous or surgical) 5. are planned to receive concomitant ablation procedure or structural heart interventions other than AF ablation and LAAO (e.g SVT ablation, Aflutter ablation, PFO closure, leadless pacemaker, ASD Closure, etc) 6. patient whom refused or cannot tolerate procedural or post procedural follow-up TEE
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Prince of Wales Hospital
Hong Kong, Shatin, 0000, Hong Kong