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

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ClinicalTrials.gov Identifier: NCT03941691
Recruitment Status : Recruiting
First Posted : May 8, 2019
Last Update Posted : May 8, 2019
Sponsor:
Collaborator:
Shanghai Shape Memory Alloy Co., Ltd.
Information provided by (Responsible Party):
Pan Xiangbin, Chinese Academy of Medical Sciences, Fuwai Hospital

Tracking Information
First Submitted Date  ICMJE May 5, 2019
First Posted Date  ICMJE May 8, 2019
Last Update Posted Date May 8, 2019
Actual Study Start Date  ICMJE April 11, 2019
Estimated Primary Completion Date April 20, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 6, 2019)
success rate of occlusion at 6 months after the surgery [ Time Frame: 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.
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: May 6, 2019)
  • Surgical technique success rate [ Time Frame: Immediately after surgery ]
    After the occluder was implanted with surgical intervention transport device (test group) or occluder and intervention transport device (control group), the occluder was released safely.
  • technique success rate [ Time Frame: Immediately after surgery ]
    After the occluder was implanted with occluder and surgical intervention transport device (test group) or occluder and intervention transport device (control group), the occluder was released safely and no occluder detachment occurred during the operation.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Trial to Evaluate the Safety and Efficacy of a Fully Degradable Ventricular Septal Defect (VSD) Closure
Official Title  ICMJE 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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Ventricular Septal Defect
Intervention  ICMJE
  • Device: Fully Absorbable VSD Occlusion System
    Under echocardiography guided treatment of VSD with a novel fully degradable clolsure system
  • Device: VSD Occluder
    Under echocardiography guided treatment of VSD with commercially available occluder.
Study Arms  ICMJE
  • Experimental: Treatment Group
    Experimental group is allocated to use novel fully degradable ventricular septal defect closure system manufactured by Shanghai shape memory alloy materials co. LTD.
    Intervention: Device: Fully Absorbable VSD Occlusion System
  • Active Comparator: Control Group
    Control Group is allocated to use Interposition conveying device for ventricular septal defect closure produced by Shanghai shape memory alloy material co. LTD.
    Intervention: Device: VSD Occluder
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: May 6, 2019)
108
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE April 20, 2021
Estimated Primary Completion Date April 20, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 1 Year to 60 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Pan Xiangbin, MD, Ph.D 010-88396666 Xiangbin428@hotmail.com
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03941691
Other Study ID Numbers  ICMJE WQKJJ001
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Pan Xiangbin, Chinese Academy of Medical Sciences, Fuwai Hospital
Study Sponsor  ICMJE Chinese Academy of Medical Sciences, Fuwai Hospital
Collaborators  ICMJE Shanghai Shape Memory Alloy Co., Ltd.
Investigators  ICMJE
Principal Investigator: Pan Xiangbin, MD, Ph.D Chinese Academy of Medical Science, Fuwai Hospital
PRS Account Chinese Academy of Medical Sciences, Fuwai Hospital
Verification Date May 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP