NCT07257614Not yet recruiting
Left Atrial Appendage Occlusion in Dialysis Patients With Atrial Fibrillation: A Multicentre Pilot Study
Source: ClinicalTrials.gov · Last updated 16 Sept 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Study type
- Observational
- Enrollment
- 40 (estimated)
- First submitted
- 20 Nov 2025
- Start date
- 5 Dec 2026
- Primary completion date
- 5 Jan 2028
- Lead sponsor
- Prince of Wales Hospital, Shatin, Hong Kong
- Diseases
- Chronic kidney disease, Stroke, Atrial fibrillation
- NCT number
- NCT07257614
What you commit to
- Study type: Observational
- Planned participants: 40
- From 5 Dec 2026 to the primary completion date, 5 Jan 2028
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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;
- Current participation in another investigational drug or device study.
Other illness
- Patients who require long-term anticoagulation for a condition other than AF, e.g. pulmonary embolism, deep vein thrombosis, anti-phospholipid syndrome
- Active infection with bacteraemia;
- Known hypersensitivity or contraindication to aspirin, clopidogrel, heparin, any device material or component (nickel titanium, PET, polypropylene), and/or contrast;
- New York Heart Association Class IV;
Lab values
- 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)
Other
- Mechanical valve replacement
- Pregnant or nursing patients and those who plan pregnancy during the study period. Female patients of childbearing potential must have a negative pregnancy
- Life expectancy is less than 1 year;
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| The Chinese Universityy of Hong Kong Coordinator of this site? Confirm its status | Shatin | Hong Kong SAR China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.