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

• Status: Recruiting
• Trial end date: 2028-05-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: China National Center for Cardiovascular Diseases
• Treatments: Anticoagulants

Criteria

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.