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

NCT04096924 | Unknown

• 1 other identifier: HYQ001
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 3

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.

Conditions

Atrial Septal Defect

Keywords

ASD; Atrial septal defects; amplatzer

Outcome Measures

Primary Outcomes (1)

• success rate

  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.

  Immediately after treatment

Secondary Outcomes (1)

• Incidence of major adverse events(MAE)

  1 month

Study Arms (2)

Treatment Group

EXPERIMENTAL

Experimental group is allocated to use novel interventional guidewire for the echocardiography guided percutaneous interventions for ASD.

Device: Guidewire for echo-guided interventions

Control Group

ACTIVE COMPARATOR

Control Group is allocated to use Cook lunderquist guidewire for the echocardiography guided percutaneous interventions for ASD.

Device: Cook lunderquist guidewire

Interventions

Guidewire for echo-guided interventions DEVICE

Under echocardiography guided treatment of ASD with a novel interventional guidewire

Treatment Group

Cook lunderquist guidewire DEVICE

Subjects with ASD treated with amplatzer using the Cook lunderquist guidewire.

Control Group

Eligibility Criteria

• Age: 2 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Chinese Academy of Medical Sciences, Fuwai Hospital: lead

Study Sites (3)

Structural Heart Disease Center, Fuwai Hospital

Beijing, Beijing Municipality, China

RECRUITING

Fuwai Huazhong Cardiovascular Hospital

Zhengzhou, Henan, China

NOT YET RECRUITING

Xinjiang People's Hospital

Ürümqi, Xinjiang, China

ACTIVE NOT RECRUITING

Related Publications (1)

• 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.

  PMID: 32847382 DERIVED

MeSH Terms

Conditions

Heart Septal Defects, Atrial

Condition Hierarchy (Ancestors)

Heart Septal Defects; Heart Defects, Congenital; Cardiovascular Abnormalities; Cardiovascular Diseases; Heart Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Xiangbin Pan, MD,Ph.D

  Chinese Academy of Medical Sciences, Fuwai Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Xiangbin Pan, MD,Ph.D

CONTACT

010-88396666; xiangbin428@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief, Department of Structural Heart Disease

Study Record Dates

• First Submitted: September 18, 2019
• First Posted: September 20, 2019
• Study Start: July 7, 2018
• Primary Completion: December 30, 2019
• Study Completion: May 30, 2020
• Last Updated: September 20, 2019

Record last verified: 2019-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (3)