Study of Blood Clotting After Transcatheter Atrial Septal Defect Closure

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

450 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-01-31

Study Completion Date

2012-06-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Study on the Significance of Auricular Clip in Prevention and Treatment of Valvular Heart Disease Atrial Thrombosis

NCT05263024

Atrial Fibrillation Thrombus; Embolism Warfarin +2 more

NOT_YET_RECRUITING

Bioabsorbable Occluder for Outlet VSD: Safety and Aortic Valve Effects

NCT07040579

Congenital Heart Defects VSD

NOT_YET_RECRUITING

Study of Platelet Activation by Severe Aortic Stenosis and Its Correction by Transcatheter Aortic Valve Implantation

NCT02504632

Aortic Stenosis

COMPLETED NA

Long-term Benefit of Aortic Stent-graft in Patients With Distal Aortic Dissection

NCT01354119

Aortic Dissection Aortic Aneurysm Stent-graft

TERMINATED PHASE4

Long-Term Outcomes in Patients With Three-Vessel Disease

NCT05007054

Three Vessel Coronary Disease

COMPLETED

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Thrombosis

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Heparin

Heparin injection 10 IU/kg/hr within 24h

Group Type ACTIVE_COMPARATOR

Low molecular weight heparin

Intervention Type DRUG

Low molecular weight heparin sodium injection 1mg/kg 2 times in 24 hour

Low molecular weight heparin sodium injection 1mg/kg 2 times per day in 3 days.

Low molecular weight heparin

Low molecular weight heparin sodium injection 1mg/kg 2 times in 24 hour

Low molecular weight heparin sodium injection 1mg/kg 2 times per day in 3 days

Group Type EXPERIMENTAL

Low molecular weight heparin

Intervention Type DRUG

Low molecular weight heparin sodium injection 1mg/kg 2 times in 24 hour

Low molecular weight heparin sodium injection 1mg/kg 2 times per day in 3 days.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Low molecular weight heparin

Low molecular weight heparin sodium injection 1mg/kg 2 times in 24 hour

Low molecular weight heparin sodium injection 1mg/kg 2 times per day in 3 days.

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Enoxaparin

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.

Minimum Eligible Age

3 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes