The Chinese Universityy of Hong Kong
Shatin, New Territories, Hong Kong
NCT Number: NCT07257614
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.
Trial opening soon.
Get Notified18 year and older
All sexes
Observational
Shatin, New Territories, Hong Kong
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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)
Time frame: 1 year
Rate of transient ischemic attack in enrolled patient at 1 year
Time frame: 1 year
Stroke rate of enrolled cases at 1-yera follow-up
Time frame: 1 year
Rate of major bleeding (BRAC 3-5) of enrolled cases at 1-year follow-up
Time frame: 1 year
Rate of systemic embolism in enrolled patient at 1 year
Time frame: 1 year
Rate of minor bleeding (BRAC 1-2) in enrolled patient at 1 year
Time frame: 7 days post-discharge
occurrence of death between the time of implant and within 7 days after hospital discharge
Time frame: 7 days post-discharge
occurrence of ischemic stroke between the time of implant and within 7 days after hospital discharge
Time frame: 7 days post-discharge
occurrence of systemic embolism between the time of implant and within 7 days after hospital discharge
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
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
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
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
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
Time frame: 1 month
Major Peri-Device Leak (>5mm) at 1 month follow-upr
Time frame: 1 month
Device Related Thrombus at 1 month follow-up
Time frame: 1 month
Rate of device endotheliasation at 1 month follow-up CT
Time frame: 3 month
Rate of device endotheliasation at 3 month follow-up CT
Time frame: 12 month
Rate of device endotheliasation at 12 month follow-up CT
Time frame: 12 month
Rate of 1-year cardiovascular mortality in enrolled cases at 12 month follow-up
Time frame: 12 month
Comparison of clinical outcome with matched cohort identified from dialysis registry will be conducted.
Contact information is provided by the study sponsor or research team.
Prince of Wales Hospital, Shatin, Hong Kong
Other
Acronym: LAAO-DAF
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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