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Trial record 2 of 8 for:    xeltis

Xeltis Bioabsorbable Pulmonary Valved Conduit Pivotal Study (Xplore2)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03022708
Recruitment Status : Enrolling by invitation
First Posted : January 16, 2017
Last Update Posted : January 6, 2022
Sponsor:
Information provided by (Responsible Party):
Xeltis

Tracking Information
First Submitted Date  ICMJE January 10, 2017
First Posted Date  ICMJE January 16, 2017
Last Update Posted Date January 6, 2022
Actual Study Start Date  ICMJE May 8, 2017
Estimated Primary Completion Date December 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 7, 2021)
Composite rate of events of device related death, re-operation or re-intervention at 12 months follow-up. [ Time Frame: 12 months ]
Measured once all 12 month follow up visits have been completed
Original Primary Outcome Measures  ICMJE
 (submitted: January 13, 2017)
  • Freedom of device related death due to device failure at 6 months follow up post implantation, measured by the fact that the patient is still alive at the time of the 6 month FU visit [ Time Frame: 6 months ]
  • Freedom of device related death at 12 months follow-up, measured by the fact that the patient is still alive at the time of the 12 month FU visit [ Time Frame: 12 months ]
  • Freedom of re-operation or re-intervention at 6 months follow-up due to device failure, measured by the fact that the patient did not have a reoperation or reintervention during the first 6 months [ Time Frame: 6 months ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 7, 2021)
  • Overall rate of device related death due to device failure at 6 months follow up post implantation. [ Time Frame: 6 months ]
    Measured once all 6 month follow up visits have been completed
  • Overall rate of mortality at 60 months follow up post implantation. [ Time Frame: 60 months ]
    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. [ Time Frame: 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. [ Time Frame: 6 and 12 months ]
    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. [ Time Frame: 6 and 12 months ]
    Measured by echography at 6 and 12 months follow up.
Original Secondary Outcome Measures  ICMJE
 (submitted: January 13, 2017)
  • Overall rate of mortality at 60 months follow up post implantation, measured by the fact that the patient is still alive at the time of the 60 month FU visit [ Time Frame: 60 months ]
  • Overall rate of subjects who require reoperation or reintervention due to device failure at 12 months, measured by the fact that the patient did not have a reoperation or reintervention during the first 12 months [ Time Frame: 12 months ]
  • Overall rate of subjects with a mean pressure gradient across the area of conduit implantation (RV to PA) of less than 40 mm Hg at 6 and 12 months follow up, measured with echocardiography at 6 and 12 months follow up. [ Time Frame: 6 and 12 months ]
  • Overall rate of subjects with pulmonary regurgitation of equal or less than moderate at 6 and 12 months follow up, measured with echocardiography at 6 and 12 months follow up. [ Time Frame: 6 and 12 months ]
Current Other Pre-specified Outcome Measures
 (submitted: June 7, 2021)
  • 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. [ Time Frame: Up to 60 months ]
    Measured with echocardiography at 6, 36, 48 and 60 months follow up.
  • Overall satisfaction of the implanting surgeon of the implantation procedure of the Bio-absorbable pulmonary valve conduit [ Time Frame: Day 0 - Implant ]
    Measured with a questionnaire given to the implanting surgeon at the time of implantation of the pulmonary valve conduit.
Original Other Pre-specified Outcome Measures
 (submitted: January 13, 2017)
  • Measurement of growth of the conduit in pediatric population at 6, 36, 48 and 60 months, measured with echocardiography at 6, 36, 48 and 60 months follow up. [ Time Frame: Up to 60 months ]
  • Overall satisfaction of the implanting surgeon of the implantation procedure of the Bioabsorbable pulmonary valved conduit, measured with a questionnaire given to the implanting surgeon at the time of implantation of the PV conduit. [ Time Frame: Day 0 - Implant ]
 
Descriptive Information
Brief Title  ICMJE Xeltis Bioabsorbable Pulmonary Valved Conduit Pivotal Study
Official Title  ICMJE 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
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Heart Defect, Congenital
Intervention  ICMJE Device: Xeltis Bioabsorbable Pulmonary Valved Conduit
Surgical implantation of Xeltis Bioabsorbable Pulmonary Valved Conduit
Study Arms  ICMJE Experimental: Xeltis Bioabsorbable Pulmonary Valved Conduit

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: Device: Xeltis Bioabsorbable Pulmonary Valved Conduit
Publications * Morales DL, Herrington C, Bacha EA, Morell VO, Prodán 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Enrolling by invitation
Estimated Enrollment  ICMJE
 (submitted: June 7, 2021)
56
Original Estimated Enrollment  ICMJE
 (submitted: January 13, 2017)
10
Estimated Study Completion Date  ICMJE December 2026
Estimated Primary Completion Date December 2023   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 2 Years to 21 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Bulgaria,   Malaysia,   Poland,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03022708
Other Study ID Numbers  ICMJE XEL-CR-03
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Current Responsible Party Xeltis
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Xeltis
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Eliane Schutte Xeltis Inc
PRS Account Xeltis
Verification Date June 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP