The study is an investigator-sponsored, prospective, multicenter, randomized, open-label study designed to compare efficacy and safety between bivalirudin and heparin in patients with non-valvular atrial fibrillation undergoing percutaneous left atrial appendage occlusion.
Bivalirudin, a direct thrombin inhibitor, emerged as an important representative of intravenous anticoagulant and has been recommended for treatment of acute coronary syndromes with percutaneous coronary intervention according to American and European guidelines.On concerns of risk of bleeding and thrombosis,bivalirudin shows significant advantages over traditional glycoprotein inhibitors(GPI).However,the research about the application of bivalirudin for patients at high-risk of stroke and bleeding with non-valvular atrial fibrillation is still at blank stage.Percutaneous left atrial appendage occlusion is nowadays an effective alternative for stroke prevention and its targeted population is featured as CHA2DS2 score≥2 and/or HAS-BLED score≥3.The purpose of this multi-center trial is to evaluate the safety and peri-procedual efficacy of bivalirudin for patients at high-risk atrial fibrillation patients undergoing percutaneous left atrial appendage occlusion.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
100
Patients would be given anticoagulant therapy with bivalirudin in left atrial appendage occusion.
heparin during left atrial appendage occlusion.
Zhongshan Hopital of Fudan University
Shanghai, Shanghai Municipality, China
Major adverse cardiac events
a composite of all cause death, stroke
Time frame: 7 days
Major bleeding
BARC types 2-5 bleeding;TIMI major bleeding or GUSTO moderate to severe bleeding
Time frame: 7 days
Creatine kinase-MB increase
creatine kinase-MB increase \>3 times upper limit of normal
Time frame: up to postprocedural 72 hours
Major bleeding
BARC types 2-5 bleeding;TIMI major bleeding or GUSTO moderate to severe bleeding
Time frame: 60 days
Major adverse cardiac events
a composite of all cause death, stroke,heart failure
Time frame: 60 days
Device-related thrombus
rate of stent thrombosis
Time frame: 60 days
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.