Clinical trial NCT04096924: A Prospective Randomized Multicenter Trial of the Guidewire for Echo-guided Interventions
Official title: A Randomized Multicenter Comparison Trial to Evaluate the Effectiveness and Safety of the Guidewire for Echo-guided Interventions in Treating ASD
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Atrial Septal Defect
Keywords: ASD
Atrial septal defects
amplatzer
Lead sponsor: Chinese Academy of Medical Sciences, Fuwai Hospital
Sponsor class: OTHER
First posted: 2019-09-20
Enrollment: 100
Sex: ALL
Minimum age (years): 2
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: success rate
timeFrame: Immediately after treatment
Secondary outcomes:
measure: Incidence of major adverse events(MAE)
timeFrame: 1 month
Other outcomes:
Locations:
city: Beijing
country: China
facility: Structural Heart Disease Center, Fuwai Hospital
state: Beijing
city: Zhengzhou
country: China
facility: Fuwai Huazhong Cardiovascular Hospital
state: Henan
city: Urumqi
country: China
facility: Xinjiang People's Hospital
state: Xinjiang
Study officials:
affiliation: Chinese Academy of Medical Sciences, Fuwai Hospital
name: Xiangbin Pan, MD,Ph.D
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kong P, Zhao G, Zhang Z, Zhang W, Fan T, Han Y, Pang K, Wang S, Zhang F, Wang W, Hu S, Pan X. Novel Panna Guide Wire Facilitates Percutaneous and Nonfluoroscopic Procedure for Atrial Septal Defect Closure: A Randomized Controlled Trial. Circ Cardiovasc Interv. 2020 Sep;13(9):e009281. doi: 10.1161/CIRCINTERVENTIONS.120.009281. Epub 2020 Aug 27.