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

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Brief Title

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

Official Title

Chinese Academy of Medical Sciences, Fuwai Hospital

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.
    

Detailed Description

      1. This is a prospective, multicenter, randomized and noninferiority clinical trial, which
           is designed to compare the effectiveness and safety with the fully absorbable
           ventricular septal defect (VSD) occlusion system and VSD occlusion system produced by
           Shanghai shape memory alloy materials co., LTD.

        2. This trial will recruit about 108 subjects from 4 centers. Patients will be randomized
           to two groups in equal proportion (54 in each). The proposal recruiting period is 12
           months and the follow-up will be performed at 1 month, 3 months and 6 months after
           surgery.
    


Study Type

Interventional


Primary Outcome

success rate of occlusion at 6 months after the surgery

Secondary Outcome

 Surgical technique success rate

Condition

Ventricular Septal Defect

Intervention

Fully Absorbable VSD Occlusion System

Study Arms / Comparison Groups

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

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Device

Estimated Enrollment

108

Start Date

April 11, 2019

Completion Date

April 20, 2021

Primary Completion Date

April 20, 2021

Eligibility Criteria

        Inclusion Criteria:

          1. 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;

          2. Aged from 1 to 60 years old, weight more than 10 kg, male or non-pregnant women;

          3. VSD effective shunt ≥3mm, ≤14mm;

          4. Distance between the edge of defect and the right aortic valve is more than 3mm, no
             aortic valve prolapse or moderate aortic regurgitation.

        Exclusion Criteria:

          1. Irreversible pulmonary vascular disease;Severe pulmonary hypertension with
             bidirectional shunt;

          2. Bleeding disorders or known clotting disorders (including heparin-induced
             thrombocytopenia),contraindications to antiplatelet therapy, or rejection of
             transfusions;

          3. Sepsis or severe infection within 1 month prior to occlusion;

          4. Patients with thrombosis at the occluder placement and venous thrombosis at the
             catheter insertion site;

          5. Cardiac malformation dependent on ventricular septal defect (VSD);

          6. Not suitable for treatment with this product.
      

Gender

All

Ages

1 Year - 60 Years

Accepts Healthy Volunteers

No

Contacts

Pan Xiangbin, MD, Ph.D, 010-88396666, [email protected]

Location Countries

China

Location Countries

China

Administrative Informations


NCT ID

NCT03941691

Organization ID

WQKJJ001


Responsible Party

Principal Investigator

Study Sponsor

Chinese Academy of Medical Sciences, Fuwai Hospital

Collaborators

 Shanghai Shape Memory Alloy Co., Ltd.

Study Sponsor

Pan Xiangbin, MD, Ph.D, Principal Investigator, Chinese Academy of Medical Science, Fuwai Hospital


Verification Date

May 2019