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.
Age >=18
End stage renal failure on peritoneal dialysis or haemodialysis
documented paroxysmal, persistent, or permanent non-valvular atrial fibrillation;
CHADS2-VASc >=2
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
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.
Cohort
Other
Not listed
1 year transient ischemic attack
Rate of transient ischemic attack in enrolled patient at 1 year
1 year stroke rate
Stroke rate of enrolled cases at 1-yera follow-up
1 year major bleeding rate
Rate of major bleeding (BRAC 3-5) of enrolled cases at 1-year follow-up
1 year systemic embolism rate
Rate of systemic embolism in enrolled patient at 1 year
1 year minor bleeding rate
Rate of minor bleeding (BRAC 1-2) in enrolled patient at 1 year
LAAO safety endpoint
occurrence of death between the time of implant and within 7 days after hospital discharge
LAAO safety endpoint
occurrence of ischemic stroke between the time of implant and within 7 days after hospital discharge
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Prince of Wales Hospital, Shatin, Hong Kong
Lead sponsor
The Queen Elizabeth Hospital
Collaborator
Pok Oi Hospital
Collaborator
Tuen Mun Hospital
Collaborator
Princess Margaret Hospital, Hong Kong
Collaborator
Alice Ho Miu Ling Nethersole Hospital
Collaborator
Kiang Wu Hospital
Collaborator
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