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

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

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.

Study Overview

• Status: Unknown
• Conditions: Atrial Septal Defect
• Intervention / Treatment: Device: Guidewire for echo-guided interventions; Device: Cook lunderquist guidewire

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 Type: Interventional
• Enrollment (Anticipated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Xiangbin Pan, MD,Ph.D; Phone Number: 010-88396666; Email: xiangbin428@hotmail.com

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China
      • Recruiting
      • Structural Heart Disease Center, Fuwai Hospital
      • Contact: Xiangbin Pan, MD,Ph.D; Phone Number: 010-88396666; Email: xiangbin428@hotmail.com
  • Henan
    • Zhengzhou, Henan, China
      • Not yet recruiting
      • Fuwai Huazhong Cardiovascular Hospital
      • Contact: Taibin Fan, MD, Ph.D
  • Xinjiang
    • Urumqi, Xinjiang, China
      • Active, not recruiting
      • Xinjiang People's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 2 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Chinese Academy of Medical Sciences, Fuwai Hospital
• Investigators: Principal Investigator: Xiangbin Pan, MD,Ph.D, Chinese Academy of Medical Sciences, Fuwai Hospital

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): July 7, 2018
• Primary Completion (Anticipated): December 30, 2019
• Study Completion (Anticipated): May 30, 2020

Study Registration Dates

• First Submitted: September 18, 2019
• First Submitted That Met QC Criteria: September 18, 2019
• First Posted (Actual): September 20, 2019

Study Record Updates

• Last Update Posted (Actual): September 20, 2019
• Last Update Submitted That Met QC Criteria: September 18, 2019
• Last Verified: September 1, 2019

More Information

Terms related to this study

• Keywords: ASD; amplatzer; Atrial septal defects
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Congenital Abnormalities; Heart Defects, Congenital; Cardiovascular Abnormalities; Heart Septal Defects; Heart Septal Defects, Atrial
• Other Study ID Numbers: HYQ001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No