Epicardial Left Atrial Appendage Clipping Versus Novel Oral Anticoagulants to Reduce Stroke Risk in Non-paroxysmal Atrial Fibrillation: a Multicenter Randomized Controlled Trial
Status: Recruiting
Location: See location...
Intervention Type: Procedure, Drug
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• 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.
Locations
Other Locations
China
China National Center for Cardiovascular Diseases
RECRUITING
Beijing
Contact Information
Primary
Zhe Zheng, MD,PhD
zhengzhe@fuwai.com
+86-010-88396051
Backup
Chunyu Yu, MD
yuchunyu@fuwai.com
Time Frame
Start Date: 2024-04-02
Estimated Completion Date: 2028-05
Participants
Target number of participants: 290
Treatments
Experimental: LAA clipping group
In this arm, participants are performed thoracoscopic LAA clipping.
Active_comparator: NOACs group
Patients randomized to NOAC therapy will begin long-term oral administration of NOACs immediately after enrollment.
Related Therapeutic Areas
Sponsors
Leads: China National Center for Cardiovascular Diseases