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New device could cut stroke risk in kidney patients on dialysis

NCT ID NCT07257614

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

About 40 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Dec 2026

An estimate. Start dates often move.

Expected to finish

Jul 2028

An estimate. End dates often move.

Lead sponsor

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

18 years and older

Sex

Anyone

Healthy volunteers

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

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.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. 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

  • The Chinese Universityy of Hong Kong

    Shatin, New Territories, Hong Kong

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Other studies related to the condition(s) this trial covers.