Heart DiseasesNCT03176225
Evaluate Safety and Effectiveness of XenoSure Biological Patch in the Application of Cardiac Repair
A study testing Open heart surgery to address the heart disease, Close the defects with XenoSure Patch and Close the defects with Chest Polyester Patch in people with Heart Diseases, run by LeMaitre Vascular at 1 site in China.
Trial summary
The purpose of this clinical trial is to collect safety and effectiveness data to support cardiac repair indication of XenoSure biologic patch. This trial is performed to meet the China FDA regulations for this kind of device. Read more about this study
- Who is it for?
- Ages Up to 6 years
- Conditions the study is for
- Heart Diseases
- What is being tested?
- Open heart surgery to address the heart disease, Close the defects with XenoSure Patch and Close the defects with Chest Polyester Patch
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 142 participants
- Where
- 1 siteChina
- Study dates
- 15 Aug 2017to 15 Feb 2024
- 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 Up to 6 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Man or woman aged below 6 years old
- The expected lifetime of no less than 12 months
- Patients with congenital heart disease in symptoms of ventricular septal defect, atrial septal defect and tetralogy of fallot who need the surgical repair.
- Physical conditions and vital signs meet requirements for the surgery.
- The subjects and/or their guardians sign the written Informed Consent Form.
Who cannot join
- Patients with severe visceral diseases in liver, kidney, etc.
- Patients have unstable vital signs and not suitable for the indications.
- Patients with severe allergic history (especially allergic to bovine materials)
- Patients with the past medical history of severe immunodeficiency disease
- The subject has used or plans to use immunomodulatory drugs for more than half a year.
- The subject with poor blood clotting function, which is defined as that pre-operative INR or APTT is prolonged over 30% than the reference value without drug intervention, or that blood platelet count is less than 100*10^9/L.
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- The subject has severe kidney disorders or diseases with the estimated glomerular filtration rate [GRF]<30mL/min/1.73m2.
- The subject's ALT or AST level is 2.5 times higher than the upper normal limit or the subject has active liver disease or icterus.
- The subject has participated in another clinical study within past 3 months or is participating in another clinical study now.
- The investigator believes that the subject has other reasons unsuitable for inclusion.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Random, Controlled, Single-blinded, Multi-center and Non-inferiority Clinical Study to Evaluate Safety and Effectiveness of XenoSure Biological Patch in the Application of Cardiac Repair
The purpose of this clinical trial is to collect safety and effectiveness data to support cardiac repair indication of XenoSure biologic patch. This trial is performed to meet the China FDA regulations for this kind of device. The clinical trial will be performed solely inside China under GCP regulation and all applicable China regulations on medical device clinical trial.
Read the detailed description
The purpose of this clinical trial is to collect safety and effectiveness data to support cardiac repair indication of XenoSure biologic patch. This trial is performed to meet the China FDA regulations for this kind of device. The clinical trial will be performed solely inside China under GCP regulation and all applicable China regulations on medical device clinical trial.
There will be 144 subjects enrolled, including 72 subjects in the trial arm and 72 subjects in the control arm.
- Conditions
- Heart Diseases
- Being tested
- Open heart surgery to address the heart disease, Close the defects with XenoSure Patch, Close the defects with Chest Polyester Patch
- Medical subject headings
- Heart Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Open heart surgery to address the heart diseaseProcedure or surgery
The patient will first have open heart surgery to achieve access to the diseased site in the heart
Close the defects with XenoSure PatchDevice
The heart defects, such as ASD (Atrial Septal Defect) or VSD (Ventricular Septal Defect ), are closed with LeMaitre XenoSure Patch.
Close the defects with Chest Polyester PatchDevice
The heart defects, such as ASD (Atrial Septal Defect) or VSD (Ventricular Septal Defect ), are closed with a Polyester Patch made by Shanghai Chest Medical Technology Co.
| Study group | Role | What they receive |
|---|---|---|
| Test Arm | Experimental | In Test Arm, the subjects will be implanted with test article - XenoSure patch. The interventions include: Open heart surgery to address the heart disease; Close the defects with XenoSure Patch Receives: Procedure: Open heart surgery to address the heart disease; Device: Close the defects with XenoSure Patch |
| Control Arm | Active comparator | In Control Arm, the subjects will be implanted with comparator device - Polyester patch by Shanghai Chest Medical Technology Co. The interventions include: Open heart surgery to address the heart disease; Close the defects with Chest Polyester Patch Receives: Procedure: Open heart surgery to address the heart disease; Device: Close the defects with Chest Polyester Patch |
What is being measured
The primary outcome is the main question the study is designed to answer.
Leakage rate at 6 month post-procedure measured by ultrasound
The heart defects should be totally closed by the patch. Any residual flow or leakage, measured by ultrasound, will be recorded. The percentage of the patients that show leakage post-procedure is the failure rate. The study is considered achieved its primary endpoint if the failure rate of the test device is non-inferior to the rate of the comparator device.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2017
- Study start15 Aug 2017
- Primary completion15 Nov 2020
- Study completion15 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart DiseasesStudies of the same condition, open and under way.
- 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 142 participants (actual)
Sponsor and investigators
- Lead sponsor
- LeMaitre Vascular
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03176225
- Sponsor's protocol ID
- P15077-1
- Status last verified
- Jul 2024
- First submitted
- 31 May 2017
- Last updated
- 10 Mar 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Random, Controlled, Single-blinded, Multi-center and Non-inferiority Clinical Study to Evaluate Safety and Effectiveness of XenoSure Biological Patch in the Application of Cardiac Repair
- ClinicalTrials.gov ID
- NCT03176225
- Acronym / sponsor ID
- P15077-1
- Conditions
- Heart Diseases
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 142 participants (actual)
- Lead sponsor
- LeMaitre VascularIndustry (pharma, biotech, devices)
- Study start
- 15 Aug 2017 (actual)
- Primary completion
- 15 Nov 2020 (actual)
- Study completion
- 15 Feb 2024 (actual)
- First posted
- 5 Jun 2017 (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 collect safety and effectiveness data to support cardiac repair indication of XenoSure biologic patch. This trial is performed to meet the China FDA regulations for this kind of device. The clinical trial will be performed solely inside China under GCP regulation and all applicable China regulations on medical device clinical trial.
Detailed description
The purpose of this clinical trial is to collect safety and effectiveness data to support cardiac repair indication of XenoSure biologic patch. This trial is performed to meet the China FDA regulations for this kind of device. The clinical trial will be performed solely inside China under GCP regulation and all applicable China regulations on medical device clinical trial.
There will be 144 subjects enrolled, including 72 subjects in the trial arm and 72 subjects in the control arm.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Test Arm | Experimental | Procedure: Open heart surgery to address the heart disease, Device: Close the defects with XenoSure PatchIn Test Arm, the subjects will be implanted with test article - XenoSure patch. The interventions include: Open heart surgery to address the heart disease; Close the defects with XenoSure Patch |
| Control Arm | Active comparator | Procedure: Open heart surgery to address the heart disease, Device: Close the defects with Chest Polyester PatchIn Control Arm, the subjects will be implanted with comparator device - Polyester patch by Shanghai Chest Medical Technology Co. The interventions include: Open heart surgery to address the heart disease; Close the defects with Chest Polyester Patch |
Who may qualify
- Ages
- Up to 6 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Man or woman aged below 6 years old
- The expected lifetime of no less than 12 months
- Patients with congenital heart disease in symptoms of ventricular septal defect, atrial septal defect and tetralogy of fallot who need the surgical repair.
- Physical conditions and vital signs meet requirements for the surgery.
- The subjects and/or their guardians sign the written Informed Consent Form.
Key exclusion criteria (10 listed)
- Patients with severe visceral diseases in liver, kidney, etc.
- Patients have unstable vital signs and not suitable for the indications.
- Patients with severe allergic history (especially allergic to bovine materials)
- Patients with the past medical history of severe immunodeficiency disease
- The subject has used or plans to use immunomodulatory drugs for more than half a year.
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 |
|---|---|---|
| Open heart surgery to address the heart diseaseThe patient will first have open heart surgery to achieve access to the diseased site in the heart | Procedure or surgery | Control Arm, Test Arm |
| Close the defects with XenoSure PatchThe heart defects, such as ASD (Atrial Septal Defect) or VSD (Ventricular Septal Defect ), are closed with LeMaitre XenoSure Patch. | Device | Test Arm |
| Close the defects with Chest Polyester PatchThe heart defects, such as ASD (Atrial Septal Defect) or VSD (Ventricular Septal Defect ), are closed with a Polyester Patch made by Shanghai Chest Medical Technology Co. | Device | Control Arm |
Primary outcome
Leakage rate at 6 month post-procedure measured by ultrasound
Time frame: 6 months
The heart defects should be totally closed by the patch. Any residual flow or leakage, measured by ultrasound, will be recorded. The percentage of the patients that show leakage post-procedure is the failure rate. The study is considered achieved its primary endpoint if the failure rate of the test device is non-inferior to the rate of the comparator device.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Mar 2025.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Open heart surgery to address the heart disease, Close the defects with XenoSure Patch and Close the defects with Chest Polyester Patch in people with Heart Diseases, run by LeMaitre Vascular at 1 site 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 5 inclusion and 10 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: finished, as of the sponsor's last update on 10 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Leakage rate at 6 month post-procedure measured by ultrasound (time frame: 6 months). 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 10 Mar 2025.