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Study of Blood Clotting After Transcatheter Atrial Septal Defect Closure

Information source: Third Military Medical University
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Thrombosis

Intervention: Low molecular weight heparin (Drug)

Phase: N/A

Status: Recruiting

Sponsored by: Third Military Medical University

Official(s) and/or principal investigator(s):
lan huang, Study Director, Affiliation: Cardiovascular Department, Xinqiao Hospital, the Third Military Medical University

Overall contact:
Jun Qin, Phone: +86 023 68755601, Email: qinjunqjqj@yahoo.com.cn

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.

Clinical Details

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

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Primary outcome: A Multicentre, Randomized Controlled Study of Blood Clotting After Percutaneous Atrial Septal Defect closure

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

Minimum age: 3 Years. Maximum age: 60 Years. Gender(s): Both.

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.

Locations and Contacts

Jun Qin, Phone: +86 023 68755601, Email: qinjunqjqj@yahoo.com.cn

Cardiovascular Department, Xinqiao Hospital, the Third Military Medical University, Chongqing, Chongqing 400037, China; Recruiting
Lan Huang, Phone: +86 023 68755601, Email: huanglan260@yahoo.com.cn
Jun Qin, Principal Investigator
Additional Information

Starting date: January 2009
Last updated: January 18, 2012

Page last updated: August 20, 2015

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