Comparing Clipping of the Heart's Left Atrial Appendage With Blood Thinners in Atrial Fibrillation
Tests a heart clipping procedure against blood-thinning pills in adults with atrial fibrillation.
Plain-language title generated from the registry record
Registry title: LAA Clipping Versus NOACs to Prevent Stroke in Non-paroxysmal Atrial Fibrillation.
Key facts
- Where
- Beijing, ChinaSee the site
Where in China
- China National Center for Cardiovascular DiseasesBeijing, ChinaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- China National Center for Cardiovascular Diseases
- Trial code
- NCT06021808
- Record updated
- 13 June 2024
- Original description
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.Read full original descriptionShow less
Epicardial Left Atrial Appendage Clipping Versus Novel Oral Anticoagulants to Reduce Stroke Risk in Non-paroxysmal Atrial Fibrillation: a Multicenter Randomized Controlled 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.
Inclusion: 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: Patients requiring dual antiplatelet drug therapy; Previous cardiac and left lung surgery; Other heart diseases with surgical indications; Ischemic stroke and other cardiac embolic events within 30 days; Major clinical bleeding event within 30 days; Active systemic infection or infective endocarditis or pericarditis; Other diseases requiring oral anticoagulants; Acute coronary syndrome within 3 months; Metal allergies; Terminal illness with a life expectancy of less than 2 years; Left ventricular ejection fraction (LVEF) < 30%; 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); With electrical cardioversion or ablation intent; Contraindications to anticoagulation; Intracardiac thrombus; Active aortic plaque; Symptomatic carotid artery stenosis; Severe left pleural and pericardial adhesions; Pregnant or breastfeeding patients; Participation in other clinical studies at the time of enrollment; Refuse to participate in this study.