Clinical trial NCT01086046: Study of Blood Clotting After Transcatheter Atrial Septal Defect Closure
Official title: A Multicentre, Randomized Controlled Study of Blood Clotting After Transcatheter Atrial Septal Defect Closure
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Thrombosis
Keywords: platelet
thrombozyme
ASD
Heparin
Enoxaparin
Lead sponsor: Third Military Medical University
Sponsor class: OTHER
Collaborators: name: Chongqing Medical University
First posted: 2010-03-12
Enrollment: 450
Sex: ALL
Minimum age (years): 3
Maximum age (years): 60
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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 description: 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.

Eligibility criteria: Inclusion Criteria:

* Age≥3 years
* Diameter of defect≥5mm and increasing volume load of right heart
* ≤36 mm secondary left to right shunt
* The distance between defective edge and coronaria venosus sinus, inferior caval vein, superior vena and pulmonary vein≥ 5 mm, between artrial-ventricular valve≥7 mm
* The diameter of defect\>Occluder
* No other cardiac anomalies need surgery intervention

Exclusion Criteria:

* Hypertension
* Coronary artery disease
* Diabetes
* Atrial fibrillation and oral contraceptive medication
* Aspro, clopidogrel and warfarin in 2 weeks.

Primary outcomes:
measure: A Multicentre, Randomized Controlled Study of Blood Clotting After Percutaneous Atrial Septal Defect closure
timeFrame: within the first 90 days after closure
Secondary outcomes:
Other outcomes:
Locations:
city: Chongqing
country: China
facility: Cardiovascular Department, Xinqiao Hospital, the Third Military Medical University
state: Chongqing
Study officials:
affiliation: Cardiovascular Department, Xinqiao Hospital, the Third Military Medical University
name: lan huang
role: STUDY_DIRECTOR
References: