Atrial Fibrillation, Chronic Kidney Disease (Stages 3b-5), Dialysis, End Stage Kidney Failure, Left Atrial Appendage Occlusion, Stroke Prevention in Patients With Atrial Fibrillation
Conditions
Brief 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. 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.
Interventions
None listed
Sponsors
Prince of Wales Hospital, Shatin, Hong Kong
The Queen Elizabeth Hospital
Pok Oi Hospital
Tuen Mun Hospital
Princess Margaret Hospital, Hong Kong
Alice Ho Miu Ling Nethersole Hospital
Kiang Wu Hospital
Study design
Observational model
COHORT
Time perspective
OTHER
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 1 year transient ischemic attack | 1 year | Rate of transient ischemic attack in enrolled patient at 1 year |
| 1 year stroke rate | 1 year | Stroke rate of enrolled cases at 1-yera follow-up |
| 1 year major bleeding rate | 1 year | Rate of major bleeding (BRAC 3-5) of enrolled cases at 1-year follow-up |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 1 year systemic embolism rate | 1 year | Rate of systemic embolism in enrolled patient at 1 year |
| 1 year minor bleeding rate | 1 year | Rate of minor bleeding (BRAC 1-2) in enrolled patient at 1 year |
| LAAO safety endpoint | 7 days post-discharge | occurrence of death between the time of implant and within 7 days after hospital discharge |
| LAAO effectiveness endpoint | 1 year | The incidence of effective LAA closure, defined as any peri-device flow ≤5 mm per core laboratory-assessed CT at 1 year |
| Peri-device leak rate at 1 month | 1 month | Major Peri-Device Leak (\>5mm) at 1 month follow-upr |
| Device Related Thrombus rate at 1 month | 1 month | Device Related Thrombus at 1 month follow-up |
| Rate of device endotheliasation at 1 month | 1 month | Rate of device endotheliasation at 1 month follow-up CT |
| Rate of device endotheliasation at 3 month | 3 month | Rate of device endotheliasation at 3 month follow-up CT |
| Rate of device endotheliasation at 12 month | 12 month | Rate of device endotheliasation at 12 month follow-up CT |
| Rate of 1-year cardiovascular mortality at 12 month | 12 month | Rate of 1-year cardiovascular mortality in enrolled cases at 12 month follow-up |
| Comparison of outcome between prospective and retrospective group | 12 month | Comparison of clinical outcome with matched cohort identified from dialysis registry will be conducted. |
Countries
Hong Kong
Contacts
CONTACTDaniel Xu
PRINCIPAL_INVESTIGATORKent Chak Yu So, Clinical Assistant Professor
Chinese University of Hong Kong
Outcome results
None listed