New device could cut stroke risk in kidney patients on dialysis
NCT ID NCT07257614
First seen Jun 27, 2026 · Last updated Sep 17, 2026 · Updated 2 times
Summary
This pilot study tests a procedure called left atrial appendage occlusion (LAAO) using the Watchman Flx PRO device in 40 dialysis patients with atrial fibrillation. The goal is to see if it safely reduces stroke and major bleeding compared to standard care. Participants will be followed for one year to track outcomes like stroke, bleeding, and device success.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Watchman Flx PRO device
- What this could lead to
- If successful, this could offer a safer stroke prevention option for dialysis patients with atrial fibrillation, reducing bleeding risks compared to standard blood thinners.
- What could go wrong
- This is a small pilot study with only 40 participants, so results may not apply broadly. The procedure carries risks like bleeding or device complications, and long-term benefits are unproven.
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.
- Participants
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About 40 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Dec 2026
An estimate. Start dates often move.
- Expected to finish
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Jul 2028
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.
Who is studied
The study employs a multicenter, single-arm prospective registry design. Eligible participants, aged ≥18 with documented AF and ESRF on peritoneal dialysis (PD) or hemodialysis (HD), will undergo LAAO using the Watchman Flx PRO device. Propensity score matched historical cohort from dialysis registry will be identified for comparison.
- Ages
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18 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: * Age \>=18 * End stage renal failure on peritoneal dialysis or haemodialysis * documented paroxysmal, persistent, or permanent non-valvular atrial fibrillation; * CHADS2-VASc \>=2 * The patient is willing and able to comply with the required medication post-procedure and follow-up evaluations; * Able to consent Exclusion Criteria: * Patients who require long-term anticoagulation for a condition other than AF, e.g. pulmonary embolism, deep vein thrombosis, anti-phospholipid syndrome * Mechanical valve replacement * Active infection with bacteraemia; * Pregnant or nursing patients and those who plan pregnancy during the study period. Female patients of childbearing potential must have a negative pregnancy * Known hypersensitivity or contraindication to aspirin, clopidogrel, heparin, any device material or component (nickel titanium, PET, polypropylene), and/or contrast; * Left atrial appendage is obliterated and surgical ligated; * Underwent any cardiac or non-cardiac interventional or surgical procedure within 30 days prior to the procedure or planned to have the interventional or surgical procedure within 60 days after implant procedure (e.g., cardioversion, ablation, percutaneous coronary intervention, etc.); * Recent (within 90 days prior to procedure) stroke, transient ischemic attack, or myocardial infarction; * New York Heart Association Class IV; * Life expectancy is less than 1 year; * Current participation in another investigational drug or device study. * Echocardiogram exclusion: i. Moderate mitral stenosis or above ii. LVEF \<30% iii. Intracardiac thrombus iv. Presence of a cardiac tumour. v. Existing circumferential pericardial effusion \>5 mm; vi. Presence of a high-risk Patent Foramen Ovale (PFO), defined as an atrial septal aneurysm (excursion \>15 mm or length \>15 mm) or large shunt (early, within 3 beats and/or substantial passage of 20 bubbles)
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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.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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The Chinese Universityy of Hong Kong
Shatin, New Territories, Hong Kong
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