RECRUITINGINTERVENTIONAL

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

Epicardial Left Atrial Appendage Clipping Versus Novel Oral Anticoagulants to Reduce Stroke Risk in Non-paroxysmal Atrial Fibrillation: a Multicenter Randomized Controlled Trial

About This Trial

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.

Who May Be Eligible (Plain English)

Who May Qualify: - 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. Who Should NOT Join This Trial: - 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. Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language

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.

Treatments Being Tested

PROCEDURE

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.

DRUG

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.

Locations (1)

China National Center for Cardiovascular Diseases

Beijing, Beijing Municipality, China