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Clinical Trial Summary

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.


Clinical Trial Description

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 Design


Related Conditions & MeSH terms

  • Evaluate the Safety and Efficacy of Bivalirudin in Decreasing Bleeding Risk
  • Hemorrhage

NCT number NCT04195997
Study type Interventional
Source Shanghai Zhongshan Hospital
Contact XIAOCHUN ZHANG, MD
Phone 8615002121366
Email 514864787@qq.com
Status Not yet recruiting
Phase Phase 4
Start date February 1, 2020
Completion date June 30, 2021