Status:
UNKNOWN
A Prospective Randomized Multicenter Trial of the Guidewire for Echo-guided Interventions
Lead Sponsor:
Chinese Academy of Medical Sciences, Fuwai Hospital
Conditions:
Atrial Septal Defect
Eligibility:
All Genders
2+ years
Phase:
NA
Brief Summary
Prospective randomized multicenter trial of about 100 subjects enrolled in 3-5 centers. Patients will be randomized to two groups in equal proportion (50 in each). To precise the function of this devi...
Detailed Description
1. This is a prospective blinded randomized multicenter comparison clinical trial followed the design of superiority trial to compare the effectiveness and safety of the guidewire for echo-guided inte...
Eligibility Criteria
Inclusion
- age≥2yrs, diameter of defect≥5 mm, central ASD with increased volume load of right heart.
- edge of defect is ≥5 mm from coronary sinus, superior and inferior vena cava, and pulmonary vein, and≥7 mm from atrioventricular valve.
- diameter of atrial septal \> left-atrium-side diameter of occlude.
- participants or guardians who can understand the purpose of this trial and voluntarily participate in and sign the informed consent form.
Exclusion
- Primary atrial septal defect.
- Sinus venosus atrial septal defects.
- Accompany with endocarditis or hemorrhagic risks.
- thrombosis in targeting area or venous thrombosis in inserting site.
- severe pulmonary artery hypertension generated right-to-left shunt.
- severe myocardial or valve disease unrelated with ASD.
- suffered infection diseases or developing infection diseases within 1 month, thrombosis in left atrium or left appendage, part or total anomalous pulmonary venous drainage.
Key Trial Info
Start Date :
July 7 2018
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 30 2020
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT04096924
Start Date
July 7 2018
End Date
May 30 2020
Last Update
September 20 2019
Active Locations (3)
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1
Structural Heart Disease Center, Fuwai Hospital
Beijing, Beijing Municipality, China
2
Fuwai Huazhong Cardiovascular Hospital
Zhengzhou, Henan, China
3
Xinjiang People's Hospital
Ürümqi, Xinjiang, China