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

Not Applicable

• Conditions: Atrial Septal Defect
• Interventions: Device: Cook lunderquist guidewire; Device: Guidewire for echo-guided interventions

• Registration Number: NCT04096924
• Lead Sponsor: Chinese Academy of Medical Sciences, Fuwai Hospital

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 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

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.

Study Timeline

• Study Start: 2018-07-07
• Status Verified: 2019-09
• Study First Submitted: 2019-09-18
• Study First Submitted QC: 2019-09-18
• Last Update Submitted: 2019-09-18
• Study First Posted: 2019-09-20
• Last Update Posted: 2019-09-20
• Primary Completion: 2019-12-30
• Study Completion: 2020-05-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control Group	Cook lunderquist guidewire	Control Group is allocated to use Cook lunderquist guidewire for the echocardiography guided percutaneous interventions for ASD.
Treatment Group	Guidewire for echo-guided interventions	Experimental group is allocated to use novel interventional guidewire for the echocardiography guided percutaneous interventions for ASD.

Primary Outcome Measures

Name	Time	Method
success rate	Immediately after treatment	The primary outcome will be the success rate, which is defined by the principles below: 1. guidewire can successfully access to left atrium through ASD.; 2. sheath can successfully access to left atrium guided by guidewire and not fall into right atrium after guidewire pullout.; 3. 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.

Secondary Outcome Measures

Name	Time	Method
Incidence of major adverse events(MAE)	1 month	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.

Trial Locations

Locations (3)

Structural Heart Disease Center, Fuwai Hospital; 🇨🇳 Beijing, Beijing, China

Fuwai Huazhong Cardiovascular Hospital; 🇨🇳 Zhengzhou, Henan, China

Xinjiang People's Hospital; 🇨🇳 Urumqi, Xinjiang, China