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Evaluate Safety and Effectiveness of XenoSure Biological Patch in the Application of Cardiac Repair

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ClinicalTrials.gov Identifier: NCT03176225
Recruitment Status : Recruiting
First Posted : June 5, 2017
Last Update Posted : February 26, 2019
Sponsor:
Information provided by (Responsible Party):
LeMaitre Vascular

Brief 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. The clinical trial will be performed solely inside China under GCP regulation and all applicable China regulations on medical device clinical trial.

Condition or disease Intervention/treatment Phase
Heart Diseases Procedure: Open heart surgery to address the heart disease Device: Close the defects with XenoSure Patch Device: Close the defects with Chest Polyester Patch Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 144 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
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
Actual Study Start Date : August 15, 2017
Estimated Primary Completion Date : June 2020
Estimated Study Completion Date : June 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Diseases

Arm Intervention/treatment
Experimental: Test Arm
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
Procedure: Open heart surgery to address the heart disease
The patient will first have open heart surgery to achieve access to the diseased site in the heart

Device: Close the defects with XenoSure Patch
The heart defects, such as ASD (Atrial Septal Defect) or VSD (Ventricular Septal Defect ), are closed with LeMaitre XenoSure Patch.

Active Comparator: Control Arm
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
Procedure: Open heart surgery to address the heart disease
The patient will first have open heart surgery to achieve access to the diseased site in the heart

Device: Close the defects with Chest Polyester Patch
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.




Primary Outcome Measures :
  1. 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.



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Ages Eligible for Study:   up to 6 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Man or woman aged below 6 years old
  2. The expected lifetime of no less than 12 months
  3. Patients with congenital heart disease in symptoms of ventricular septal defect, atrial septal defect and tetralogy of fallot who need the surgical repair.
  4. Physical conditions and vital signs meet requirements for the surgery.
  5. The subjects and/or their guardians sign the written Informed Consent Form.

Exclusion Criteria:

  1. Patients with severe visceral diseases in liver, kidney, etc.
  2. Patients have unstable vital signs and not suitable for the indications.
  3. Patients with severe allergic history (especially allergic to bovine materials)
  4. Patients with the past medical history of severe immunodeficiency disease
  5. The subject has used or plans to use immunomodulatory drugs for more than half a year.
  6. 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.
  7. The subject has severe kidney disorders or diseases with the estimated glomerular filtration rate [GRF]<30mL/min/1.73m2.
  8. 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.
  9. The subject has participated in another clinical study within past 3 months or is participating in another clinical study now.
  10. The investigator believes that the subject has other reasons unsuitable for inclusion.

Information from the National Library of Medicine

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): NCT03176225


Contacts
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Contact: Vic Zhang 781-425-1729 xzhang@lemaitre.com

Locations
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China, Beijing
Chinese PLA General Hospital Recruiting
Beijing, Beijing, China, 100853
Contact: Vic Zhang    7814251729    xzhang@lemaitre.com   
Sponsors and Collaborators
LeMaitre Vascular

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Responsible Party: LeMaitre Vascular
ClinicalTrials.gov Identifier: NCT03176225     History of Changes
Other Study ID Numbers: P15077-1
First Posted: June 5, 2017    Key Record Dates
Last Update Posted: February 26, 2019
Last Verified: February 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: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Additional relevant MeSH terms:
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Heart Diseases
Cardiovascular Diseases