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Clinical Trials in China / NCT06021808
Recruiting Not applicable

LAA Clipping Versus NOACs to Prevent Stroke in Non-paroxysmal Atrial Fibrillation.

NCT06021808 · tracked via the Priya Life Science China tracker
Sponsor
China National Center for Cardiovascular Diseases
Phase
Not applicable
Started
2024-04-02
Last updated
2024-06-13

Condition(s) studied

Non-paroxysmal Atrial Fibrillation

Investigational drug(s) / intervention(s)

Thoracoscopic LAA clippingNovel oral anticoagulant

Thoracoscopic LAA clipping: The surgeons measured the length of the base of the LAA, an appropriately sized LAA clip is then inserted with the aid of a thoracoscope and placed parallel to the base of the LAA.

Novel oral anticoagulant: For patients with creatinine clearance ≥50 ml/min, oral rivaroxaban 20 mg daily was administered, whereas for patients with creatinine clearance between 30-49 ml/min, oral rivaroxaban 15 mg daily was administered.

Study summary

This trial is designed to examine the hypothesis that thoracoscopic LAA clipping is superior to NOACs for stroke, systemic embolism, all-cause mortality, major bleeding events and clinically relevant nonmajor bleeding events in AF patients at high risk of embolism (CHA2DS2-VASc ≥2 in men and ≥3 in women) that are not undergoing ablation.

Eligibility

Sex
ALL
Min age
18 Years
Max age
Healthy volunteers
No
Inclusion Criteria: * Age ≥ 18 years. * Persistent or long-standing persistent AF documented by medical history or direct electrocardiogram. * CHA2DS2-VASc ≥2 in men and ≥3 in women. * Agree to perform thoracoscopic LAA occlusion procedure. Exclusion Criteria: * With electrical cardioversion or ablation intent. * Other heart diseases with surgical indications. * Ischemic stroke and other cardiac embolic events within 30 days. * Major clinical bleeding event within 30 days. * Contraindications to anticoagulation. * Intracardiac thrombus. * Left ventricular ejection fraction (LVEF) \< 30%. * Active systemic infection or infective endocarditis or pericarditis * Severe liver disease (acute clinical hepatitis, chronic active hepatitis, cirrhosis) or alanine transaminase (ALT)/ aspartate transaminase (AST) greater than 3 times the upper limit of normal value. * Severe renal insufficiency (eGFR ≤ 30mL/min). * Other diseases requiring oral anticoagulants. * Active aortic plaque. * Acute coronary syndrome within 3 months. * Symptomatic carotid artery stenosis. * Patients requiring dual antiplatelet drug therapy. * Previous cardiac and left lung surgery. * Severe left pleural and pericardial adhesions. * Pregnant or breastfeeding patients. * Metal allergies. * Terminal illness with a life expectancy of less than 2 years. * Participation in other clinical studies at the time of enrollment. * Refuse to participate in this study.

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
China National Center for Cardiovascular Diseases Beijing Beijing Municipality Recruiting

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Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06021808 on ClinicalTrials.gov ↗ ← All trials in China