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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
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

Study Description
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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.

Condition or disease Intervention/treatment Phase
Ventricular Septal Defect Device: Fully Absorbable VSD Occlusion System Device: VSD Occluder Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 108 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Chinese Academy of Medical Sciences, Fuwai Hospital
Actual Study Start Date : April 11, 2019
Estimated Primary Completion Date : April 20, 2021
Estimated Study Completion Date : April 20, 2021

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
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.
 Device: Fully Absorbable VSD Occlusion System
Under echocardiography guided treatment of VSD with a novel fully degradable clolsure 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.
 Device: VSD Occluder
Under echocardiography guided treatment of VSD with commercially available occluder.


Outcome Measures
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Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.


Eligibility Criteria
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Ages Eligible for Study:   1 Year to 60 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03941691


Contacts
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Contact: Pan Xiangbin, MD, Ph.D 010-88396666 Xiangbin428@hotmail.com

Locations
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China, Anhui
Hefei high-tech cardiovascular hospital Not yet recruiting
Hefei, Anhui, China
Contact: Fang Weiyi, MD, Ph.D    0551-65722947    fwychest@163.com   
China, Beijing
Structral Heart Disease Center, Fuwai Hospital Recruiting
Beijing, Beijing, China
Contact: Pan Xiangbin, MD, Ph.D    010-88396666    xiangbin428@hotmail.com   
China, Changsha
The Second XIANGYA Hospital Of Central South University Not yet recruiting
Hunan, Changsha, China
Contact: Tianli Zhao, MD, Ph.D    18807489179    zhaotianli69@126.com   
China, Jiangsu
Children's Hospital Nanjing Medical University Not yet recruiting
Nanjing, Jiangsu, China
Contact: Mo Xuming, MD, Ph.D    18951769006    mohsuming15@sina.com   
Sponsors and Collaborators
Chinese Academy of Medical Sciences, Fuwai Hospital
Shanghai Shape Memory Alloy Co., Ltd.
Investigators
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Principal Investigator: Pan Xiangbin, MD, Ph.D Chinese Academy of Medical Science, Fuwai Hospital
  Study Documents (Full-Text)

Documents provided by Pan Xiangbin, Chinese Academy of Medical Sciences, Fuwai Hospital:
Study Protocol and Statistical Analysis Plan  [PDF] June 5, 2018
Informed Consent Form  [PDF] November 1, 2018

More Information
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Responsible Party: Pan Xiangbin, Principal Investigator, Chinese Academy of Medical Sciences, Fuwai Hospital
ClinicalTrials.gov Identifier: NCT03941691    
Other Study ID Numbers: WQKJJ001
First Posted: May 8, 2019    Key Record Dates
Last Update Posted: May 8, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Pan Xiangbin, Chinese Academy of Medical Sciences, Fuwai Hospital:
VSD
Ventriculai Septal Defects
amplatzer
Additional relevant MeSH terms:
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Heart Septal Defects
Heart Septal Defects, Ventricular
Heart Defects, Congenital
Cardiovascular Abnormalities
 Cardiovascular Diseases
Heart Diseases
Congenital Abnormalities