A Prospective Randomized Multicenter Trial of the Guidewire for Echo-guided Interventions

Study Overview
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Brief Summary
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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.

Detailed Description
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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. 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.

Official Title
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A Randomized Multicenter Comparison Trial to Evaluate the Effectiveness and Safety of the Guidewire for Echo-guided Interventions in Treating ASD

Conditions
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Atrial Septal Defect

Intervention / Treatment
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* Device: Guidewire for echo-guided interventions
* Device: Cook lunderquist guidewire


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Criteria: 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.

Ages Eligible for Study
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Minimum Age: 2 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment Group<br>Experimental group is allocated to use novel interventional guidewire for the echocardiography guided percutaneous interventions for ASD. | Device: Guidewire for echo-guided interventions<br>* Under echocardiography guided treatment of ASD with a novel interventional guidewire<br>|
| Active Comparator: Control Group<br>Control Group is allocated to use Cook lunderquist guidewire for the echocardiography guided percutaneous interventions for ASD. | Device: Cook lunderquist guidewire<br>* Subjects with ASD treated with amplatzer using the Cook lunderquist guidewire.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| success rate | The primary outcome will be the success rate, which is defined by the principles below: guidewire can successfully access to left atrium through ASD. sheath can successfully access to left atrium guided by guidewire and not fall into right atrium after guidewire pullout. guidewire can be successfully pulled out. The secondary outcome will be duration of procedure, times of arrhythmia, times of misguided to tricuspid valve, cardiac perforation, cardiac tamponed, complications in peripheral vessels. | Immediately after treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of major adverse events(MAE) | MAE definition: Any complications related to devices or surgeries, including but not limited to: death, emergency surgery, severe cardiac tamponade requiring pericardiocentesis or operation, hemorrhage, stroke related to operation. | 1 month | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ASD, Atrial septal defects, amplatzer