Ventricular Septal DefectNCT03941691
A Trial to Evaluate the Safety and Efficacy of a Fully Degradable Ventricular Septal Defect (VSD) Closure
A study testing Fully Absorbable VSD Occlusion System and VSD Occluder in people with Ventricular Septal Defect, run by Chinese Academy of Medical Sciences, Fuwai Hospital at 4 sites in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 1 year to 60 years
- Conditions the study is for
- Ventricular Septal Defect
- What is being tested?
- Fully Absorbable VSD Occlusion System and VSD Occluder
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 108 participants
- Where
- 4 sitesChina
- Study dates
- 11 Apr 2019to 20 Apr 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 year to 60 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
4 sites in 1 country.
China4 sites, 4 recruiting
- Recruiting
Structral Heart Disease Center, Fuwai Hospital
Beijing, Beijing Municipality
Pan Xiangbin, MD, Ph.D, 010-88396666, xiangbin428@hotmail.com
- Not yet recruiting
Hefei high-tech cardiovascular hospital
Hefei, Anhui
Fang Weiyi, MD, Ph.D, 0551-65722947, fwychest@163.com
- Not yet recruiting
The Second XIANGYA Hospital Of Central South University
Hunan, Changsha
Tianli Zhao, MD, Ph.D, 18807489179, zhaotianli69@126.com
- Not yet recruiting
Children's Hospital Nanjing Medical University
Nanjing, Jiangsu
Mo Xuming, MD, Ph.D, 18951769006, mohsuming15@sina.com
About this study
Official title: Chinese Academy of Medical Sciences, Fuwai Hospital
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.
Read the 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.
- Conditions
- Ventricular Septal Defect
- Being tested
- Fully Absorbable VSD Occlusion System, VSD Occluder
- Keywords
- VSD, Ventriculai Septal Defects, amplatzer
- Medical subject headings
- Heart Septal Defects, Ventricular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fully Absorbable VSD Occlusion SystemDevice
Under echocardiography guided treatment of VSD with a novel fully degradable clolsure system
VSD OccluderDevice
Under echocardiography guided treatment of VSD with commercially available occluder.
| Study group | Role | What they receive |
|---|---|---|
| Treatment Group | Experimental | Experimental group is allocated to use novel fully degradable ventricular septal defect closure system manufactured by Shanghai shape memory alloy materials co. LTD. Receives: Device: Fully Absorbable VSD Occlusion System |
| Control Group | Active comparator | Control Group is allocated to use Interposition conveying device for ventricular septal defect closure produced by Shanghai shape memory alloy material co. LTD. Receives: Device: VSD Occluder |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 months after the surgery
Secondary outcomes (2)
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.
Measured: Immediately after surgery
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.
Measured: Immediately after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2019
- Study start11 Apr 2019
- Primary completion20 Apr 2021 (estimated)
- Study completion20 Apr 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ventricular Septal DefectStudies of the same condition, open and under way.
- More trials run by Chinese Academy of Medical Sciences, Fuwai HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 108 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Shanghai Shape Memory Alloy Co., Ltd.
- Responsible party
- Principal investigator, Pan Xiangbin, Chinese Academy of Medical Sciences, Fuwai Hospital
- Investigators
- Pan Xiangbin, MD, Ph.D, Principal investigator, Chinese Academy of Medical Science, Fuwai Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03941691
- Sponsor's protocol ID
- WQKJJ001
- Status last verified
- May 2019
- First submitted
- 5 May 2019
- Last updated
- 8 May 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Chinese Academy of Medical Sciences, Fuwai Hospital
- ClinicalTrials.gov ID
- NCT03941691
- Acronym / sponsor ID
- WQKJJ001
- Conditions
- Ventricular Septal Defect
- Keywords
- VSD, Ventriculai Septal Defects, amplatzer
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 108 participants (estimated)
- Lead sponsor
- Chinese Academy of Medical Sciences, Fuwai HospitalUniversity, hospital or other
- Collaborators
- Shanghai Shape Memory Alloy Co., Ltd.
- Study start
- 11 Apr 2019 (actual)
- Primary completion
- 20 Apr 2021 (estimated)
- Study completion
- 20 Apr 2021 (estimated)
- First posted
- 8 May 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment Group | Experimental | Device: Fully Absorbable VSD Occlusion SystemExperimental group is allocated to use novel fully degradable ventricular septal defect closure system manufactured by Shanghai shape memory alloy materials co. LTD. |
| Control Group | Active comparator | Device: VSD OccluderControl Group is allocated to use Interposition conveying device for ventricular septal defect closure produced by Shanghai shape memory alloy material co. LTD. |
Who may qualify
- Ages
- 1 year to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (6 listed)
- 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);
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fully Absorbable VSD Occlusion SystemUnder echocardiography guided treatment of VSD with a novel fully degradable clolsure system | Device | Treatment Group |
| VSD OccluderUnder echocardiography guided treatment of VSD with commercially available occluder. | Device | Control Group |
Primary outcome
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.
2 secondary outcomes
Surgical technique success rate
Time frame: Immediately after surgery
technique success rate
Time frame: Immediately after surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pan Xiangbin, MD, Ph.D principal investigator
Chinese Academy of Medical Science, Fuwai Hospital
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fully Absorbable VSD Occlusion System and VSD Occluder in people with Ventricular Septal Defect, run by Chinese Academy of Medical Sciences, Fuwai Hospital at 4 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 May 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Pan Xiangbin, MD, Ph.D (010-88396666, Xiangbin428@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
success rate of occlusion at 6 months after the surgery (time frame: 6 months after the surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 May 2019.