Xeltis Bioabsorbable Pulmonary Valved Conduit Pivotal Study

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Heart Defect, Congenital

Intervention / Treatment
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* Device: Xeltis Bioabsorbable Pulmonary Valved Conduit


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 2 Years
Maximum Age: 21 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Xeltis Bioabsorbable Pulmonary Valved Conduit<br>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. | Device: Xeltis Bioabsorbable Pulmonary Valved Conduit<br>* Surgical implantation of Xeltis Bioabsorbable Pulmonary Valved Conduit<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 6 months | 
| Overall rate of mortality at 60 months follow up post implantation. | Measured once all 60 months follow up visits have been completed | 60 months | 
| 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 . | 12 months | 
| 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. | 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 by echography at 6 and 12 months follow up. | 6 and 12 months |