DialysisLAAO-DAFNCT07257614
Left Atrial Appendage Occlusion in Dialysis Patients With Atrial Fibrillation: A Multicentre Pilot Study
An observational study of Dialysis and Chronic Kidney Disease (Stages 3b-5), run by Prince of Wales Hospital, Shatin, Hong Kong at 1 site in Hong Kong.
Trial summary
Objectives: This pilot study aims to evaluate the safety and efficacy of left atrial appendage occlusion (LAAO) in dialysis patients and atrial fibrillation (AF) to establish a novel stroke prevention strategy and determine an optimal post-occlusion antithrombotic regime. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Dialysis, Chronic Kidney Disease (Stages 3b-5), Atrial Fibrillation
- How many people
- 40 participants
- Where
- 1 siteHong Kong
- Study dates
- 5 Dec 2026to 5 Jul 2028
- How long will I take part?
- 1 Year
- Phase
- Observational
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
Study population: 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.
Who may be able to join
- 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
Who cannot join
- 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;
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- 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:
- 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)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Hong Kong1 site
The Chinese Universityy of Hong Kong
Shatin, New Territories
Jia Lin Daniel Nursing Officer, 85235051518, xjldaniel@gmail.com
About this study
Objectives: This pilot study aims to evaluate the safety and efficacy of left atrial appendage occlusion (LAAO) in dialysis patients and atrial fibrillation (AF) to establish a novel stroke prevention strategy and determine an optimal post-occlusion antithrombotic regime. Page 3 of 50 Hypothesis: The study tests the hypotheses that LAAO is safe for dialysis patients, that a single antiplatelet regimen postprocedure is safe, and that LAAO effectively reduces the composite endpoint of stroke/transient ischemic attack and major bleeding compared to standard care. Instruments: 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.
Main Outcome Measures: The primary endpoint is the composite of stroke/transient ischemic attack/systemic embolism and non-procedural-related major bleeding at one year. Secondary endpoints include individual rates of these events, procedural safety and device occlusion effectiveness. Data Analysis and Expected Results: Statistical analysis will involve descriptive statistics, chi-squared tests, and propensity score matching. A p-value of <0.05 will be deemed significant. The pilot study anticipates a low peri-procedural complication rate (≤5%) and confirms LAAO's efficacy in stroke and major bleeding reduction in Chinese PD and HD patients compared to standard care. This data will inform the design of a larger randomized controlled trial aimed at validating LAAO as a safe alternative for AF management in dialysis populations.
- Conditions
- Dialysis, Chronic Kidney Disease (Stages 3b-5), Atrial Fibrillation, End Stage Kidney Failure, Stroke Prevention in Patients With Atrial Fibrillation, Left Atrial Appendage Occlusion
- Medical subject headings
- Renal Insufficiency, Chronic, Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Prospective cohort | 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, follow-up for 1 year post-operation to track their outcome | |
| Retrospective cohort | Comparison of clinical outcomes (1 year stroke/TIA, major bleeding and CV death) with matched cohort identified from exisiting dialysis registry will be conducted. |
What is being measured
The primary outcome is the main question the study is designed to answer.
1 year transient ischemic attack
Rate of transient ischemic attack in enrolled patient at 1 year
Measured: 1 year
1 year stroke rate
Stroke rate of enrolled cases at 1-yera follow-up
Measured: 1 year
1 year major bleeding rate
Rate of major bleeding (BRAC 3-5) of enrolled cases at 1-year follow-up
Measured: 1 year
Secondary outcomes (17)
1 year systemic embolism rate
Rate of systemic embolism in enrolled patient at 1 year
Measured: 1 year
1 year minor bleeding rate
Rate of minor bleeding (BRAC 1-2) in enrolled patient at 1 year
Measured: 1 year
LAAO safety endpoint
occurrence of death between the time of implant and within 7 days after hospital discharge
Measured: 7 days post-discharge
LAAO safety endpoint
occurrence of ischemic stroke between the time of implant and within 7 days after hospital discharge
Measured: 7 days post-discharge
LAAO safety endpoint
occurrence of systemic embolism between the time of implant and within 7 days after hospital discharge
Measured: 7 days post-discharge
LAAO safety endpoint
occurrence of device-related events requiring open cardiac surgery between the time of implant and within 7 days after hospital discharge
Measured: 7 days post-discharge
LAAO safety endpoint
occurrence of device-related events requiring major endovascular intervention between the time of implant and within 7 days after hospital discharge
Measured: 7 days post-discharge
LAAO safety endpoint
occurrence of procedure-related events requiring open cardiac surgery between the time of implant and within 7 days after hospital discharge
Measured: 7 days post-discharge
LAAO safety endpoint
occurrence of procedure-related events requiring major endovascular intervention between the time of implant and within 7 days after hospital discharge
Measured: 7 days post-discharge
LAAO effectiveness endpoint
The incidence of effective LAA closure, defined as any peri-device flow ≤5 mm per core laboratory-assessed CT at 1 year
Measured: 1 year
Peri-device leak rate at 1 month
Major Peri-Device Leak (>5mm) at 1 month follow-upr
Measured: 1 month
Device Related Thrombus rate at 1 month
Device Related Thrombus at 1 month follow-up
Measured: 1 month
Rate of device endotheliasation at 1 month
Rate of device endotheliasation at 1 month follow-up CT
Measured: 1 month
Rate of device endotheliasation at 3 month
Rate of device endotheliasation at 3 month follow-up CT
Measured: 3 month
Rate of device endotheliasation at 12 month
Rate of device endotheliasation at 12 month follow-up CT
Measured: 12 month
Rate of 1-year cardiovascular mortality at 12 month
Rate of 1-year cardiovascular mortality in enrolled cases at 12 month follow-up
Measured: 12 month
Comparison of outcome between prospective and retrospective group
Comparison of clinical outcome with matched cohort identified from dialysis registry will be conducted.
Measured: 12 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2025
- Study start5 Dec 2026 (estimated)
- Primary completion5 Jan 2028 (estimated)
- Study completion5 Jul 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DialysisStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 40 participants (estimated)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Prince of Wales Hospital, Shatin, Hong Kong
- Sponsor type
- University, hospital or other
- Collaborators
- The Queen Elizabeth Hospital, Pok Oi Hospital, Tuen Mun Hospital, Princess Margaret Hospital, Hong Kong, Alice Ho Miu Ling Nethersole Hospital, Kiang Wu Hospital
- Responsible party
- Principal investigator, Dr So Chak Yu kent, Prince of Wales Hospital, Shatin, Hong Kong
- Investigators
- Kent Chak Yu So, Clinical Assistant Professor, Principal investigator, Chinese University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07257614
- Sponsor's protocol ID
- 2025.630
- Acronym
- LAAO-DAF
- Status last verified
- Sep 2026
- First submitted
- 20 Nov 2025
- Last updated
- 16 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No