A Prospective Randomized Multicenter Trial of the Guidewire for Echo-guided Interventions
A Prospective Randomized Multicenter Trial of the Guidewire for Echo-guided Interventions
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 device on reducing technical difficulties and conquering learning curves, it
 is required that the doctor should be able to independently do echo-guided percutaneous
 interventions and his cases should be more than 20 but less than 100. Experimental group is
 allocated to use novel interventional guidewire for echocardiography guided percutaneous
 interventions for ASD, control group will be treated by cook lunderquist guidewire. If
 echo-guided procedure does not work well, the procedure will be immediately replaced by
 conventional procedure guided by radiology. To evaluate the effectiveness and safety
 comprehensively, variables are defined as success rate, duration of procedure, times of
 arrhythmia, times of misguided to tricuspid valve, cardiac perforation, cardiac tamponed,
 complications in peripheral vessels etc.
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 interventions designed by Hangzhou Dexin Medical Technological Company
 with other similar products.

 2. This trial will enroll about 100 subjects from 3-5 centers. Patients will be randomized
 to two groups in equal proportion (50 in each). Proposal recruiting period is 18 months
 and follow-up will be performed for 30 days.
Inclusion Criteria:

 1. age≥2yrs, diameter of defect≥5 mm, central ASD with increased volume load of right
 heart.

 2. edge of defect is ≥5 mm from coronary sinus, superior and inferior vena cava, and
 pulmonary vein, and≥7 mm from atrioventricular valve.

 3. diameter of atrial septal > left-atrium-side diameter of occlude.

 4. participants or guardians who can understand the purpose of this trial and voluntarily
 participate in and sign the informed consent form.

 Exclusion Criteria:

 1. Primary atrial septal defect.

 2. Sinus venosus atrial septal defects.

 3. Accompany with endocarditis or hemorrhagic risks.

 4. thrombosis in targeting area or venous thrombosis in inserting site.

 5. severe pulmonary artery hypertension generated right-to-left shunt.

 6. severe myocardial or valve disease unrelated with ASD.

 7. suffered infection diseases or developing infection diseases within 1 month,
 thrombosis in left atrium or left appendage, part or total anomalous pulmonary venous
 drainage.