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)
Rate of composite endpoint — At 24-month after intervention Stroke, systemic embolism, all-cause mortality, major bleeding event, and clinically relevant non-major bleeding event.
Trial sites (1)
Facility
City
Region
Status
China National Center for Cardiovascular Diseases
Beijing
Beijing Municipality
Recruiting
More China National Center for Cardiovascular Diseases trials in China
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.
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