A Trial to Evaluate the Safety and Efficacy of a Fully Degradable Ventricular Septal Defect (VSD) Closure

NCT03941691 | Unknown

• 1 other identifier: WQKJJ001
• Study Type: interventional
• Target: 108
• Locations: 1 country
• Sites: 4

Brief Summary

The purpose of this clinical trial is to verify the safety and effectiveness of the Fully Absorbable VSD Occlusion System and VSD Occlusion System produced by Shanghai shape memory alloy materials co., LTD. Clinical trials are designed as prospective, multicenter, randomized controlled, noninferiority clinical trials. Prospective randomized multicenter trial involving about 108 subjects will be enrolled in 4 centers. Patients will be randomized to two groups in equal proportion (54 in each). The success rate of occlusion at 6 months after operation is the main evaluation index in this clinical trial.

Conditions

Ventricular Septal Defect

Keywords

VSD; Ventriculai Septal Defects; amplatzer

Outcome Measures

Primary Outcomes (1)

• success rate of occlusion at 6 months after the surgery

  Successful occlusion is that when follow-up under echocardiography at 6 months after surgery, the occlusion site shows no residual shunt or only a small amount of residual shunt.

  6 months after the surgery

Secondary Outcomes (2)

• Surgical technique success rate

  Immediately after surgery

• technique success rate

  Immediately after surgery

Study Arms (2)

Treatment Group

EXPERIMENTAL

Experimental group is allocated to use novel fully degradable ventricular septal defect closure system manufactured by Shanghai shape memory alloy materials co. LTD.

Device: Fully Absorbable VSD Occlusion System

Control Group

ACTIVE COMPARATOR

Control Group is allocated to use Interposition conveying device for ventricular septal defect closure produced by Shanghai shape memory alloy material co. LTD.

Device: VSD Occluder

Interventions

Fully Absorbable VSD Occlusion System DEVICE

Under echocardiography guided treatment of VSD with a novel fully degradable clolsure system

Treatment Group

VSD Occluder DEVICE

Under echocardiography guided treatment of VSD with commercially available occluder.

Control Group

Eligibility Criteria

• Age: 1 Year - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Subjects and/or their legal guardians will be informed of the nature of this study and agree to participate in this clinical trial in accordance with all terms of this study.Signed the informed consent approved by the ethics committee, agreed to accept the postoperative treatment program, and completed the follow-up and related examinations as required by the follow-up;
• Aged from 1 to 60 years old, weight more than 10 kg, male or non-pregnant women;
• VSD effective shunt ≥3mm, ≤14mm;
• Distance between the edge of defect and the right aortic valve is more than 3mm, no aortic valve prolapse or moderate aortic regurgitation.

You may not qualify if:

• Irreversible pulmonary vascular disease;Severe pulmonary hypertension with bidirectional shunt;
• Bleeding disorders or known clotting disorders (including heparin-induced thrombocytopenia),contraindications to antiplatelet therapy, or rejection of transfusions;
• Sepsis or severe infection within 1 month prior to occlusion;
• Patients with thrombosis at the occluder placement and venous thrombosis at the catheter insertion site;
• Cardiac malformation dependent on ventricular septal defect (VSD);
• Not suitable for treatment with this product.

Sponsors & Collaborators

• Chinese Academy of Medical Sciences, Fuwai Hospital: lead
• Shanghai Shape Memory Alloy Co., Ltd.: collaborator

Study Sites (4)

Hefei high-tech cardiovascular hospital

Hefei, Anhui, China

NOT YET RECRUITING

Structral Heart Disease Center, Fuwai Hospital

Beijing, Beijing Municipality, China

RECRUITING

The Second XIANGYA Hospital Of Central South University

Hunan, Changsha, China

NOT YET RECRUITING

Children's Hospital Nanjing Medical University

Nanjing, Jiangsu, China

NOT YET RECRUITING

MeSH Terms

Conditions

Heart Septal Defects, Ventricular

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

• Pan Xiangbin, MD, Ph.D

  Chinese Academy of Medical Science, Fuwai Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Pan Xiangbin, 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: Principal Investigator

Study Record Dates

• First Submitted: May 5, 2019
• First Posted: May 8, 2019
• Study Start: April 11, 2019
• Primary Completion: April 20, 2021
• Study Completion: April 20, 2021
• Last Updated: May 8, 2019

Record last verified: 2019-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (4)