Left Atrial Appendage Occlusion in Dialysis Patients With Atrial Fibrillation: A Multicentre Pilot Study (LAAO-DAF)

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Atrial Fibrillation; Dialysis; Left Atrial Appendage Occlusion; Stroke Prevention in Patients With Atrial Fibrillation; Chronic Kidney Disease (Stages 3b-5); End Stage Kidney Failure

• Study Type: Observational
• Enrollment (Estimated): 40

Contacts and Locations

• Study Contact: Name: Daniel Xu; Phone Number: 852-35051518; Email: xjldaniel@gmail.com

Study Locations

• Hong Kong
  • New Territories
    • Shatin, New Territories, Hong Kong
      • The Chinese Universityy of Hong Kong
      • Contact: Jia Lin Daniel Nursing Officer; Phone Number: 85235051518; Email: xjldaniel@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

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.

Description

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)

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
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 the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
1 year transient ischemic attack	Rate of transient ischemic attack in enrolled patient at 1 year	1 year
1 year stroke rate	Stroke rate of enrolled cases at 1-yera follow-up	1 year
1 year major bleeding rate	Rate of major bleeding (BRAC 3-5) of enrolled cases at 1-year follow-up	1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
1 year systemic embolism rate	Rate of systemic embolism in enrolled patient at 1 year	1 year
1 year minor bleeding rate	Rate of minor bleeding (BRAC 1-2) in enrolled patient at 1 year	1 year
LAAO safety endpoint	occurrence of death between the time of implant and within 7 days after hospital discharge	7 days post-discharge
LAAO safety endpoint	occurrence of ischemic stroke between the time of implant and within 7 days after hospital discharge	7 days post-discharge
LAAO safety endpoint	occurrence of systemic embolism between the time of implant and within 7 days after hospital discharge	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	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	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	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	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	1 year
Peri-device leak rate at 1 month	Major Peri-Device Leak (>5mm) at 1 month follow-upr	1 month
Device Related Thrombus rate at 1 month	Device Related Thrombus at 1 month follow-up	1 month
Rate of device endotheliasation at 1 month	Rate of device endotheliasation at 1 month follow-up CT	1 month
Rate of device endotheliasation at 3 month	Rate of device endotheliasation at 3 month follow-up CT	3 month
Rate of device endotheliasation at 12 month	Rate of device endotheliasation at 12 month follow-up CT	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	12 month
Comparison of outcome between prospective and retrospective group	Comparison of clinical outcome with matched cohort identified from dialysis registry will be conducted.	12 month

Collaborators and Investigators

• Sponsor: Prince of Wales Hospital, Shatin, Hong Kong
• Collaborators: Tuen Mun Hospital; The Queen Elizabeth Hospital; Princess Margaret Hospital, Hong Kong; Pok Oi Hospital; Kiang Wu Hospital; Alice Ho Miu Ling Nethersole Hospital
• Investigators: Principal Investigator: Kent Chak Yu So, Clinical Assistant Professor, Chinese University of Hong Kong

Study record dates

Study Major Dates

• Study Start (Estimated): January 5, 2026
• Primary Completion (Estimated): January 5, 2028
• Study Completion (Estimated): July 5, 2028

Study Registration Dates

• First Submitted: November 20, 2025
• First Submitted That Met QC Criteria: November 20, 2025
• First Posted (Estimated): December 2, 2025

Study Record Updates

• Last Update Posted (Estimated): December 4, 2025
• Last Update Submitted That Met QC Criteria: December 2, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urogenital Diseases; Cardiovascular Diseases; Pathologic Processes; Male Urogenital Diseases; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Heart Diseases; Chronic Disease; Disease Attributes; Arrhythmias, Cardiac; Renal Insufficiency; Pathological Conditions, Signs and Symptoms; Atrial Fibrillation; Renal Insufficiency, Chronic
• Other Study ID Numbers: 2025.630

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No