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NCT Number: NCT07257614

Left Atrial Appendage Occlusion in Dialysis Patients With Atrial Fibrillation: A Multicentre Pilot 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.

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Key information

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Primary outcomes

  1. 1 year transient ischemic attack

    Time frame: 1 year

    Rate of transient ischemic attack in enrolled patient at 1 year

  2. 1 year stroke rate

    Time frame: 1 year

    Stroke rate of enrolled cases at 1-yera follow-up

  3. 1 year major bleeding rate

    Time frame: 1 year

    Rate of major bleeding (BRAC 3-5) of enrolled cases at 1-year follow-up

Secondary outcomes

  1. 1 year systemic embolism rate

    Time frame: 1 year

    Rate of systemic embolism in enrolled patient at 1 year

  2. 1 year minor bleeding rate

    Time frame: 1 year

    Rate of minor bleeding (BRAC 1-2) in enrolled patient at 1 year

  3. LAAO safety endpoint

    Time frame: 7 days post-discharge

    occurrence of death between the time of implant and within 7 days after hospital discharge

  4. LAAO safety endpoint

    Time frame: 7 days post-discharge

    occurrence of ischemic stroke between the time of implant and within 7 days after hospital discharge

  5. LAAO safety endpoint

    Time frame: 7 days post-discharge

    occurrence of systemic embolism between the time of implant and within 7 days after hospital discharge

  6. LAAO safety endpoint

    Time frame: 7 days post-discharge

    occurrence of device-related events requiring open cardiac surgery between the time of implant and within 7 days after hospital discharge

  7. LAAO safety endpoint

    Time frame: 7 days post-discharge

    occurrence of device-related events requiring major endovascular intervention between the time of implant and within 7 days after hospital discharge

  8. LAAO safety endpoint

    Time frame: 7 days post-discharge

    occurrence of procedure-related events requiring open cardiac surgery between the time of implant and within 7 days after hospital discharge

  9. LAAO safety endpoint

    Time frame: 7 days post-discharge

    occurrence of procedure-related events requiring major endovascular intervention between the time of implant and within 7 days after hospital discharge

  10. LAAO effectiveness endpoint

    Time frame: 1 year

    The incidence of effective LAA closure, defined as any peri-device flow ≤5 mm per core laboratory-assessed CT at 1 year

  11. Peri-device leak rate at 1 month

    Time frame: 1 month

    Major Peri-Device Leak (>5mm) at 1 month follow-upr

  12. Device Related Thrombus rate at 1 month

    Time frame: 1 month

    Device Related Thrombus at 1 month follow-up

  13. Rate of device endotheliasation at 1 month

    Time frame: 1 month

    Rate of device endotheliasation at 1 month follow-up CT

  14. Rate of device endotheliasation at 3 month

    Time frame: 3 month

    Rate of device endotheliasation at 3 month follow-up CT

  15. Rate of device endotheliasation at 12 month

    Time frame: 12 month

    Rate of device endotheliasation at 12 month follow-up CT

  16. Rate of 1-year cardiovascular mortality at 12 month

    Time frame: 12 month

    Rate of 1-year cardiovascular mortality in enrolled cases at 12 month follow-up

  17. Comparison of outcome between prospective and retrospective group

    Time frame: 12 month

    Comparison of clinical outcome with matched cohort identified from dialysis registry will be conducted.

Study contacts

Contact information is provided by the study sponsor or research team.

Daniel Xu

CONTACT

[email protected]

852-35051518

Sponsors and collaborators

Lead sponsor

Prince of Wales Hospital, Shatin, Hong Kong

Other

Collaborators

  • Alice Ho Miu Ling Nethersole Hospital
  • Kiang Wu Hospital
  • Pok Oi Hospital
  • Princess Margaret Hospital, Hong Kong
  • The Queen Elizabeth Hospital
  • Tuen Mun Hospital

Registry information

Acronym: LAAO-DAF

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Dec 2, 2025
Registry last updated
Dec 4, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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