LAA Clipping Versus NOACs to Prevent Stroke in Non-paroxysmal Atrial Fibrillation.
Recruiting · NCT06021808 · Interventional (participants receive a specific treatment) · Lead sponsor: China National Center for Cardiovascular Diseases
View the official record on ClinicalTrials.gov →Interventions studied
Novel oral anticoagulantThoracoscopic LAA clipping
What this trial is about
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 can take part
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
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.
Where it is running
1 location listed.
- China National Center for Cardiovascular Diseases - Beijing, Beijing Municipality, China