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

Last updated: May 6, 2019
Sponsor: Chinese Academy of Medical Sciences, Fuwai Hospital
Overall Status: Active - Recruiting

Phase

N/A

Condition

Pentalogy Of Cantrell

Heart Defect

Treatment

N/A

Clinical Study ID

NCT03941691
WQKJJ001
  • Ages 1-60
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Subjects and/or their legal guardians will be informed of the nature of this study andagree to participate in this clinical trial in accordance with all terms of thisstudy.Signed the informed consent approved by the ethics committee, agreed to acceptthe postoperative treatment program, and completed the follow-up and relatedexaminations 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, noaortic valve prolapse or moderate aortic regurgitation.

Exclusion

Exclusion Criteria:

  1. Irreversible pulmonary vascular disease;Severe pulmonary hypertension withbidirectional shunt;

  2. Bleeding disorders or known clotting disorders (including heparin-inducedthrombocytopenia),contraindications to antiplatelet therapy, or rejection oftransfusions;

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

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

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

  6. Not suitable for treatment with this product.

Study Design

Total Participants: 108
Study Start date:
April 11, 2019
Estimated Completion Date:
April 20, 2021

Study 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.

Connect with a study center

  • Hefei high-tech cardiovascular hospital

    Hefei, Anhui
    China

    Site Not Available

  • Structral Heart Disease Center, Fuwai Hospital

    Beijing, Beijing
    China

    Active - Recruiting

  • The Second XIANGYA Hospital Of Central South University

    Hunan, Changsha
    China

    Site Not Available

  • Children's Hospital Nanjing Medical University

    Nanjing, Jiangsu
    China

    Site Not Available

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.