NCT06021808 LAA Clipping Versus NOACs to Prevent Stroke in Non-paroxysmal Atrial Fibrillation.
| NCT ID | NCT06021808 |
| Status | Recruiting |
| Phase | — |
| Sponsor | China National Center for Cardiovascular Diseases |
| Condition | Non-paroxysmal Atrial Fibrillation |
| Study Type | INTERVENTIONAL |
| Enrollment | 290 participants |
| Start Date | 2024-04-02 |
| Primary Completion | 2028-04 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 290 participants in total. It began in 2024-04-02 with a primary completion date of 2028-04.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 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.
Eligibility 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.
Contact & Investigator
Zhe Zheng, MD,PhD
STUDY CHAIR
Chinese Academy of Medical Sciences, Fuwai Hospital
Frequently Asked Questions
Who can join the NCT06021808 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Non-paroxysmal Atrial Fibrillation. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06021808 currently recruiting?
Yes, NCT06021808 is actively recruiting participants. Contact the research team at zhengzhe@fuwai.com for enrollment information.
Where is the NCT06021808 trial being conducted?
This trial is being conducted at Beijing, China.
Who is sponsoring the NCT06021808 clinical trial?
NCT06021808 is sponsored by China National Center for Cardiovascular Diseases. The principal investigator is Zhe Zheng, MD,PhD at Chinese Academy of Medical Sciences, Fuwai Hospital. The trial plans to enroll 290 participants.
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