Clinical Trial: Study of Blood Clotting After Transcatheter Atrial Septal Defect Closure

Study Status: Recruiting
Recruit Status: Unknown status
Study Type: Interventional

Official Title: A Multicentre, Randomized Controlled Study of Blood Clotting After Transcatheter Atrial Septal Defect Closure

Brief Summary: The purpose of this study is to evaluate blood clots after Percutaneous ASD Closure in different age, sexuality and defective diameter; evaluating the relationship of blood clotting with Occluder, injury of intima and inflammation;comparation of the effect and safety between different anticoagulation after Percutaneous ASD Repair; explore propose an optimal anticoagulation plan.

Detailed Summary: Atrial septal defect (ASD) is a common clinical congenital heart disease. It is estimated that the congenital heart disease increase in children by about 15 million annual in China , of which ASD accounted for 10% to 15%. Secundum ASD is the most common clinical type of ASD, of which about 70% is suited to tanscatheter close.With the cardiac catheterization advancing and the devices developing in recent years ,the method has gradually replaced open-chest surgical repair to the person with Secundum ASD. At present, the most widely used device is Amplatzer occluder. With the wide ues of the occlur,there has gradually emerged occluder thrombosis after closure.there are much different methods to antiplatelet and anticoagulation，not only in China but also in the world.so we perfom the study to evaluating the blood clotting after Percutaneous ASD Closure in different age, sexuality and defective diameter; evaluating the relationship of blood clotting with Occluder, injury of intima and inflammation;comparation of the effect and safety between different anticoagulation after Percutaneous ASD Repair; explore propose an optimal anticoagulation plan.
Sponsor: Third Military Medical University

Current Primary Outcome: A Multicentre, Randomized Controlled Study of Blood Clotting After Percutaneous Atrial Septal Defect closure [ Time Frame: within the first 90 days after closure ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

Original Secondary Outcome:

Information By: Third Military Medical University

Dates:
Date Received: March 8, 2010
Date Started: January 2009
Date Completion: June 2012
Last Updated: January 18, 2012
Last Verified: January 2012