Status:
RECRUITING
LAA Clipping Versus NOACs to Prevent Stroke in Non-paroxysmal Atrial Fibrillation.
Lead Sponsor:
China National Center for Cardiovascular Diseases
Conditions:
Non-paroxysmal Atrial Fibrillation
Eligibility:
All Genders
18+ years
Phase:
NA
Brief 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 ...
Detailed Description
Atrial fibrillation (AF) is the most prevalent cardiac arrhythmia disease, and the incidence of AF increases markedly with age and approximately doubles with each decade. According to the previous stu...
Eligibility Criteria
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
- 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.
Key Trial Info
Start Date :
April 2 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 1 2028
Estimated Enrollment :
290 Patients enrolled
Trial Details
Trial ID
NCT06021808
Start Date
April 2 2024
End Date
May 1 2028
Last Update
June 13 2024
Active Locations (1)
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1
China National Center for Cardiovascular Diseases
Beijing, Beijing Municipality, China, 100037