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

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

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.

Conditions2

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