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Xeltis Bioabsorbable Pulmonary Valved Conduit Pivotal Study (Xplore2)

Primary Purpose

Heart Defect, Congenital

Status
Enrolling by invitation
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Xeltis Bioabsorbable Pulmonary Valved Conduit
Sponsored by
Xeltis
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Heart Defect, Congenital

Eligibility Criteria

2 Years - 21 Years (Child, Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Patient requiring RVOT reconstruction, suitable for 16 mm,18 mm, 20 mm and 22 mm valved conduit.
  2. Male or Female.
  3. Age > 2 years and < 22 years.
  4. Right Ventricular to Pulmonary Artery peak gradient > 35mm Hg or moderate or severe Pulmonary regurgitation (≥3+), or have both (except for the patients undergoing a Ross procedure)
  5. The patient, and the patient's parent / legal representative where appropriate, has been informed of the nature of the study, agrees to its provisions and has provided written informed consent by signing the approved informed consent form.
  6. The patient, and the patient's parent / legal representative where appropriate, and the treating physician agree that the subject will return for all required post-procedure follow up visits and the subject will comply with clinical investigation plan required follow-up visits.

Exclusion Criteria:

  1. Need for or presence of prosthetic heart valve at other position.
  2. Need for concomitant surgical procedures (non-cardiac).
  3. Patients with previously implanted pacemaker (including defibrillators), or mechanical valves.
  4. Active infection or requiring current antibiotic therapy (if temporary illness, subject may be a candidate 4 weeks after discontinuation of antibiotics) or viral infection.
  5. Active endocarditis.
  6. Leukopenia, defined as White Blood cell Count < than:

    • 2-12 years: 5.0 ×103 /μL
    • 12 years - Adult:
    • Male: 4.5×103 /μL
    • Female: 4.5 ×103 /μL
  7. Acute or chronic anemia, defined as Hemoglobin < than:

    • 2-12 years 11.5 g /dl
    • 12-18:
    • Male: 13 g /dl
    • Female 12 g /dl
    • Adult:
    • Male: 13.5 g /dl
    • Female: 12 g /dl Patients can be transfused to meet eligibility criteria
  8. Thrombocytopenia, defined as Platelet count < than:

    • 150,000/mm3 Patients can be transfused to meet eligibility criteria
  9. Severe chest wall deformity, which would preclude placement of the PV conduit.
  10. Pulmonary hypertension (≥ half of systemic systolic pressure)
  11. Right ventricular outflow tract aneurysm.
  12. Known hypersensitivity to anticoagulants and antiplatelet drugs and to the device materials. .
  13. Immunocompromised patient defined as: autoimmune disease, patients receiving immunosuppressant drugs or immune stimulant drugs.
  14. Subject has chronic inflammatory / autoimmune disease.
  15. Need for emergency cardiac or vascular surgery or intervention.
  16. Major or progressive non-cardiac disease (liver failure, renal failure, cancer) that has a life expectancy of less than one year.
  17. Currently participating, or participated within the last 30 days, in an investigational drug or device study.
  18. Alcohol or drug abuse as defined by DSM IV-TR criteria for substance abuse - this includes the illicit use of cannabis within the last 12 months.
  19. Pregnancy.
  20. Females who are sexually active and are not willing to use adequate contraceptive precautions for the next 2 years
  21. Subject has medical, social or psychosocial factors that, in the opinion of the Investigator, could impact safety or compliance.

Sites / Locations

  • Children's Hospital of Los Angeles
  • Children's Hospital Colorado
  • Joe DiMaggio Children's Hospital
  • New York Presbyterian Hospital - Columbia University (Xplore1)
  • Cincinnati Children's Hospital Medical Center
  • Children's Hospital of Pittsburgh of UPMC (Xplore1)
  • UTSW- Dallas Children's Hospital
  • Multiprofile Hospital for Active Treatment "National cardiology hospital" EAD, Department of Congenital Heart Defects Surgery
  • Institut Jantung Negara Sdn Bhd
  • University Children's Hospital of Cracow

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Xeltis Bioabsorbable Pulmonary Valved Conduit

Arm Description

The Bioabsorbable Pulmonary Valved Conduit bio-absorbable, polymer-based medical device. The PV conduit is used in patients for correction or reconstruction of the Right Ventricular Outflow Tract (RVOT), in patients less than 22 years with any of the following congenital heart malformations: Tetralogy of Fallot Truncus Arteriosus Pulmonary Atresia Transposition of Great Arteries with Ventricular Septal Defect Pulmonary Stenosis in combination with other defects in congenital heart defect (CHD) syndromes In addition, the PV conduit can be used for the following indications: replacement of previously implanted, but dysfunctional, pulmonary homografts or valved conduits (except for mechanical valves, see exclusion criterion 3). Patients undergoing a Ross procedure, where the PV conduit would replace the patient's own pulmonary valve which is used to replace a diseased aortic valve.

Outcomes

Primary Outcome Measures

Composite rate of events of device related death, re-operation or re-intervention at 12 months follow-up.
Measured once all 12 month follow up visits have been completed

Secondary Outcome Measures

Overall rate of device related death due to device failure at 6 months follow up post implantation.
Measured once all 6 month follow up visits have been completed
Overall rate of mortality at 60 months follow up post implantation.
Measured once all 60 months follow up visits have been completed
Overall rate of subjects who require reoperation or re-intervention due to device failure 12 months.
Measured once all 12 month follow upvisits have been completed .
Overall rate of subjects with a mean pressure gradient across the area of conduit implantation of less than 40 mm Hg at 6 and 12 months follow up.
Measured by echography at 6 and 12 months follow up.
Overall rate of subjects with pulmonary regurgitation of equal or less than moderate at 6 and 12 months follow up.
Measured by echography at 6 and 12 months follow up.

Full Information

First Posted
January 10, 2017
Last Updated
January 24, 2023
Sponsor
Xeltis
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1. Study Identification

Unique Protocol Identification Number
NCT03022708
Brief Title
Xeltis Bioabsorbable Pulmonary Valved Conduit Pivotal Study
Acronym
Xplore2
Official Title
Prospective, Non-randomized, Pivotal Study to Assess the Safety and Efficacy of the Bioabsorbable Pulmonary Valved Conduit in Subjects Undergoing Right Ventricular Outflow Tract (RVOT) Reconstruction
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Enrolling by invitation
Study Start Date
May 8, 2017 (Actual)
Primary Completion Date
December 2023 (Anticipated)
Study Completion Date
December 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Xeltis

4. Oversight

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
Yes
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This is a multi-center prospective, single-arm, non-randomized, pivotal study that will continue to access the feasibility of the Xeltis Bioabsorbable Pulmonary Valved Conduit in subjects requiring right ventricular outflow tract correction or reconstruction due to congenital heart malformations.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Defect, Congenital

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
56 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Xeltis Bioabsorbable Pulmonary Valved Conduit
Arm Type
Experimental
Arm Description
The Bioabsorbable Pulmonary Valved Conduit bio-absorbable, polymer-based medical device. The PV conduit is used in patients for correction or reconstruction of the Right Ventricular Outflow Tract (RVOT), in patients less than 22 years with any of the following congenital heart malformations: Tetralogy of Fallot Truncus Arteriosus Pulmonary Atresia Transposition of Great Arteries with Ventricular Septal Defect Pulmonary Stenosis in combination with other defects in congenital heart defect (CHD) syndromes In addition, the PV conduit can be used for the following indications: replacement of previously implanted, but dysfunctional, pulmonary homografts or valved conduits (except for mechanical valves, see exclusion criterion 3). Patients undergoing a Ross procedure, where the PV conduit would replace the patient's own pulmonary valve which is used to replace a diseased aortic valve.
Intervention Type
Device
Intervention Name(s)
Xeltis Bioabsorbable Pulmonary Valved Conduit
Intervention Description
Surgical implantation of Xeltis Bioabsorbable Pulmonary Valved Conduit
Primary Outcome Measure Information:
Title
Composite rate of events of device related death, re-operation or re-intervention at 12 months follow-up.
Description
Measured once all 12 month follow up visits have been completed
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Overall rate of device related death due to device failure at 6 months follow up post implantation.
Description
Measured once all 6 month follow up visits have been completed
Time Frame
6 months
Title
Overall rate of mortality at 60 months follow up post implantation.
Description
Measured once all 60 months follow up visits have been completed
Time Frame
60 months
Title
Overall rate of subjects who require reoperation or re-intervention due to device failure 12 months.
Description
Measured once all 12 month follow upvisits have been completed .
Time Frame
12 months
Title
Overall rate of subjects with a mean pressure gradient across the area of conduit implantation of less than 40 mm Hg at 6 and 12 months follow up.
Description
Measured by echography at 6 and 12 months follow up.
Time Frame
6 and 12 months
Title
Overall rate of subjects with pulmonary regurgitation of equal or less than moderate at 6 and 12 months follow up.
Description
Measured by echography at 6 and 12 months follow up.
Time Frame
6 and 12 months
Other Pre-specified Outcome Measures:
Title
Measurement of growth of conduit in pediatric population measured at 6, 36, 48 and 60 months. A competent valve with increased valve diameter in age groups < 18 years in correlation with the increased body surface area.
Description
Measured with echocardiography at 6, 36, 48 and 60 months follow up.
Time Frame
Up to 60 months
Title
Overall satisfaction of the implanting surgeon of the implantation procedure of the Bio-absorbable pulmonary valve conduit
Description
Measured with a questionnaire given to the implanting surgeon at the time of implantation of the pulmonary valve conduit.
Time Frame
Day 0 - Implant

10. Eligibility

Sex
All
Minimum Age & Unit of Time
2 Years
Maximum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patient requiring RVOT reconstruction, suitable for 16 mm,18 mm, 20 mm and 22 mm valved conduit. Male or Female. Age > 2 years and < 22 years. Right Ventricular to Pulmonary Artery peak gradient > 35mm Hg or moderate or severe Pulmonary regurgitation (≥3+), or have both (except for the patients undergoing a Ross procedure) The patient, and the patient's parent / legal representative where appropriate, has been informed of the nature of the study, agrees to its provisions and has provided written informed consent by signing the approved informed consent form. The patient, and the patient's parent / legal representative where appropriate, and the treating physician agree that the subject will return for all required post-procedure follow up visits and the subject will comply with clinical investigation plan required follow-up visits. Exclusion Criteria: Need for or presence of prosthetic heart valve at other position. Need for concomitant surgical procedures (non-cardiac). Patients with previously implanted pacemaker (including defibrillators), or mechanical valves. Active infection or requiring current antibiotic therapy (if temporary illness, subject may be a candidate 4 weeks after discontinuation of antibiotics) or viral infection. Active endocarditis. Leukopenia, defined as White Blood cell Count < than: 2-12 years: 5.0 ×103 /μL 12 years - Adult: Male: 4.5×103 /μL Female: 4.5 ×103 /μL Acute or chronic anemia, defined as Hemoglobin < than: 2-12 years 11.5 g /dl 12-18: Male: 13 g /dl Female 12 g /dl Adult: Male: 13.5 g /dl Female: 12 g /dl Patients can be transfused to meet eligibility criteria Thrombocytopenia, defined as Platelet count < than: 150,000/mm3 Patients can be transfused to meet eligibility criteria Severe chest wall deformity, which would preclude placement of the PV conduit. Pulmonary hypertension (≥ half of systemic systolic pressure) Right ventricular outflow tract aneurysm. Known hypersensitivity to anticoagulants and antiplatelet drugs and to the device materials. . Immunocompromised patient defined as: autoimmune disease, patients receiving immunosuppressant drugs or immune stimulant drugs. Subject has chronic inflammatory / autoimmune disease. Need for emergency cardiac or vascular surgery or intervention. Major or progressive non-cardiac disease (liver failure, renal failure, cancer) that has a life expectancy of less than one year. Currently participating, or participated within the last 30 days, in an investigational drug or device study. Alcohol or drug abuse as defined by DSM IV-TR criteria for substance abuse - this includes the illicit use of cannabis within the last 12 months. Pregnancy. Females who are sexually active and are not willing to use adequate contraceptive precautions for the next 2 years Subject has medical, social or psychosocial factors that, in the opinion of the Investigator, could impact safety or compliance.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eliane Schutte
Organizational Affiliation
Xeltis Inc
Official's Role
Study Director
Facility Information:
Facility Name
Children's Hospital of Los Angeles
City
Los Angeles
State/Province
California
ZIP/Postal Code
90027
Country
United States
Facility Name
Children's Hospital Colorado
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Facility Name
Joe DiMaggio Children's Hospital
City
Hollywood
State/Province
Florida
ZIP/Postal Code
33021
Country
United States
Facility Name
New York Presbyterian Hospital - Columbia University (Xplore1)
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
Facility Name
Cincinnati Children's Hospital Medical Center
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45229
Country
United States
Facility Name
Children's Hospital of Pittsburgh of UPMC (Xplore1)
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15224
Country
United States
Facility Name
UTSW- Dallas Children's Hospital
City
Dallas
State/Province
Texas
ZIP/Postal Code
75390-8835
Country
United States
Facility Name
Multiprofile Hospital for Active Treatment "National cardiology hospital" EAD, Department of Congenital Heart Defects Surgery
City
Sofia
Country
Bulgaria
Facility Name
Institut Jantung Negara Sdn Bhd
City
Kuala Lumpur
Country
Malaysia
Facility Name
University Children's Hospital of Cracow
City
Kraków
Country
Poland

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
33748192
Citation
Morales DL, Herrington C, Bacha EA, Morell VO, Prodan Z, Mroczek T, Sivalingam S, Cox M, Bennink G, Asch FM. A Novel Restorative Pulmonary Valve Conduit: Early Outcomes of Two Clinical Trials. Front Cardiovasc Med. 2021 Mar 4;7:583360. doi: 10.3389/fcvm.2020.583360. eCollection 2020.
Results Reference
derived

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Xeltis Bioabsorbable Pulmonary Valved Conduit Pivotal Study

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