Actively Recruiting
LAA Clipping Versus NOACs to Prevent Stroke in Non-paroxysmal Atrial Fibrillation.
Led by China National Center for Cardiovascular Diseases · Updated on 2024-06-13
290
Participants Needed
1
Research Sites
212 weeks
Total Duration
On this page
AI-Summary
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.
CONDITIONS
Official Title
LAA Clipping Versus NOACs to Prevent Stroke in Non-paroxysmal Atrial Fibrillation.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Persistent or long-standing persistent atrial fibrillation documented by medical history or electrocardiogram
- CHA2DS2-VASc score of 2 or higher in men, 3 or higher in women
- Agreement to undergo thoracoscopic left atrial appendage occlusion procedure
You will not qualify if you...
- Planned electrical cardioversion or ablation
- Other heart diseases requiring surgery
- Ischemic stroke or cardiac embolic events within 30 days
- Major bleeding event within 30 days
- Contraindications to anticoagulation
- Presence of intracardiac thrombus
- Left ventricular ejection fraction less than 30%
- Active systemic infection, infective endocarditis, or pericarditis
- Severe liver disease or elevated liver enzymes more than three times normal
- Severe kidney failure with eGFR 30 mL/min or less
- Other diseases requiring oral anticoagulants
- Active aortic plaque
- Acute coronary syndrome within past 3 months
- Symptomatic carotid artery stenosis
- Need for dual antiplatelet therapy
- Previous heart or left lung surgery
- Severe left pleural or pericardial adhesions
- Pregnant or breastfeeding
- Metal allergies
- Terminal illness with life expectancy under 2 years
- Participation in other clinical trials at enrollment
- Refusal to participate in the study
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
China National Center for Cardiovascular Diseases
Beijing, Beijing Municipality, China, 100037
Actively Recruiting
Research Team
Z
Zhe Zheng, MD,PhD
CONTACT
C
Chunyu Yu, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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