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

Atrial Septal Defect Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04096924
• Other study ID #: HYQ001
• Status: Recruiting
• Phase: N/A
• Start date: July 7, 2018
• Est. completion date: May 30, 2020

Study information

• Verified date: September 2019
• Source: Chinese Academy of Medical Sciences, Fuwai Hospital
• Contact: Xiangbin Pan, MD,Ph.D
• Phone: 010-88396666
• Email: xiangbin428[@]hotmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: May 30, 2020
• Est. primary completion date: December 30, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 2 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Atrial Septal Defect
• Heart Septal Defects
• Heart Septal Defects, Atrial

Intervention

Device:
• Guidewire for echo-guided interventions
Under echocardiography guided treatment of ASD with a novel interventional guidewire
• Cook lunderquist guidewire
Subjects with ASD treated with amplatzer using the Cook lunderquist guidewire.

Locations

Country	Name	City	State
China	Structural Heart Disease Center, Fuwai Hospital	Beijing	Beijing
China	Xinjiang People's Hospital	Urumqi	Xinjiang
China	Fuwai Huazhong Cardiovascular Hospital	Zhengzhou	Henan

Sponsors (1)

Lead Sponsor	Collaborator
Chinese Academy of Medical Sciences, Fuwai Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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