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Prospective, Non-randomized, Open Label Clinical Study to Assess the Feasibility of the Bioabsorbable Pulmonary Valved Conduit in Subjects Undergoing Right Ventricular Outflow Tract (RVOT) Reconstruction (NCT03022708)

This is a multi-center prospective, single-arm, non-randomized, open label study to assess feasibility of the Xeltis Bioabsorbable Pulmonary Valved Conduit in subjects requiring Right Ventricular Outflow Tract correction or reconstruction due to congenital heart malformations.
  • Device: Xeltis Bioabsorbable Pulmonary Valved Conduit
    Surgical implantation of Xeltis Bioabsorbable Pulmonary Valved Conduit
    Ages eligible for Study
    2 Years to 21 Years
    Genders eligible for Study
    Accepts Healthy Volunteers
    Inclusion Criteria:
    • Patient requiring RVOT reconstruction, suitable for 16 mm or 18 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.
    • 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.

    4 locations

    United States (4)
    • Children's Healthcare of Atlanta
      Atlanta, Georgia, United States, 30322
    • Boston Children's Hospital
      Boston, Massachusetts, United States, 02115
    • New York Presbyterian Hospital - Columbia University
      New York, New York, United States, 10032
    • The Children's Hospital of Philadelphia
      Philadelphia, Pennsylvania, United States, 19104
    07 May, 2017
    21 September, 2017
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