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

• ClinicalTrials.gov Identifier: NCT03941691
• Recruitment Status: Recruiting
• First Posted: May 8, 2019
• Last Update Posted: May 8, 2019
• Sponsor: Chinese Academy of Medical Sciences, Fuwai Hospital
• 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: May 5, 2019
• First Posted Date: May 8, 2019
• Last Update Posted Date: May 8, 2019
• Actual Study Start Date: April 11, 2019
• Estimated Primary Completion Date: April 20, 2021 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (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: Same as current
• Change History: No Changes Posted

Current Secondary Outcome Measures (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: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• 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
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Ventricular Septal Defect

Intervention

• 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

• 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

Recruitment Information

• Recruitment Status: Recruiting
• Estimated Enrollment (submitted: May 6, 2019): 108
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: April 20, 2021
• Estimated Primary Completion Date: April 20, 2021 (Final data collection date for primary outcome measure)

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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 1 Year to 60 Years (Child, Adult)
• Accepts Healthy Volunteers: No

Contacts

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

• Listed Location Countries: China

Administrative Information

• NCT Number: NCT03941691
• Other Study ID Numbers: 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

• Plan to Share IPD: No

• Responsible Party: Pan Xiangbin, Chinese Academy of Medical Sciences, Fuwai Hospital
• Study Sponsor: Chinese Academy of Medical Sciences, Fuwai Hospital
• Collaborators: Shanghai Shape Memory Alloy Co., Ltd.

Investigators

• 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