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

Primary Purpose

Ventricular Septal Defect

Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Fully Absorbable VSD Occlusion System
VSD Occluder
Sponsored by
Chinese Academy of Medical Sciences, Fuwai Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ventricular Septal Defect focused on measuring VSD, Ventriculai Septal Defects, amplatzer

Eligibility Criteria

1 Year - 60 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Hefei high-tech cardiovascular hospital
  • Structral Heart Disease Center, Fuwai HospitalRecruiting
  • The Second XIANGYA Hospital Of Central South University
  • Children's Hospital Nanjing Medical University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Treatment Group

Control Group

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Surgical technique success rate
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
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.

Full Information

First Posted
May 5, 2019
Last Updated
May 6, 2019
Sponsor
Chinese Academy of Medical Sciences, Fuwai Hospital
Collaborators
Shanghai Shape Memory Alloy Co., Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT03941691
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
Study Type
Interventional

2. Study Status

Record Verification Date
May 2019
Overall Recruitment Status
Unknown status
Study Start Date
April 11, 2019 (Actual)
Primary Completion Date
April 20, 2021 (Anticipated)
Study Completion Date
April 20, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Chinese Academy of Medical Sciences, Fuwai Hospital
Collaborators
Shanghai Shape Memory Alloy Co., Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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
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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ventricular Septal Defect
Keywords
VSD, Ventriculai Septal Defects, amplatzer

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
108 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Treatment Group
Arm Type
Experimental
Arm Description
Experimental group is allocated to use novel fully degradable ventricular septal defect closure system manufactured by Shanghai shape memory alloy materials co. LTD.
Arm Title
Control Group
Arm Type
Active Comparator
Arm Description
Control Group is allocated to use Interposition conveying device for ventricular septal defect closure produced by Shanghai shape memory alloy material co. LTD.
Intervention Type
Device
Intervention Name(s)
Fully Absorbable VSD Occlusion System
Intervention Description
Under echocardiography guided treatment of VSD with a novel fully degradable clolsure system
Intervention Type
Device
Intervention Name(s)
VSD Occluder
Intervention Description
Under echocardiography guided treatment of VSD with commercially available occluder.
Primary Outcome Measure Information:
Title
success rate of occlusion at 6 months after the surgery
Description
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.
Time Frame
6 months after the surgery
Secondary Outcome Measure Information:
Title
Surgical technique success rate
Description
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.
Time Frame
Immediately after surgery
Title
technique success rate
Description
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.
Time Frame
Immediately after surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
1 Year
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Pan Xiangbin, MD, Ph.D
Phone
010-88396666
Email
Xiangbin428@hotmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pan Xiangbin, MD, Ph.D
Organizational Affiliation
Chinese Academy of Medical Science, Fuwai Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hefei high-tech cardiovascular hospital
City
Hefei
State/Province
Anhui
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Fang Weiyi, MD, Ph.D
Phone
0551-65722947
Email
fwychest@163.com
Facility Name
Structral Heart Disease Center, Fuwai Hospital
City
Beijing
State/Province
Beijing
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Pan Xiangbin, MD, Ph.D
Phone
010-88396666
Email
xiangbin428@hotmail.com
Facility Name
The Second XIANGYA Hospital Of Central South University
City
Hunan
State/Province
Changsha
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tianli Zhao, MD, Ph.D
Phone
18807489179
Email
zhaotianli69@126.com
Facility Name
Children's Hospital Nanjing Medical University
City
Nanjing
State/Province
Jiangsu
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mo Xuming, MD, Ph.D
Phone
18951769006
Email
mohsuming15@sina.com

12. IPD Sharing Statement

Plan to Share IPD
No

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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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