Xeltis Pulmonary Valved Conduit Safety and Performance Study

Study Overview
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Brief Summary
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This is a multi-center prospective, single-arm, non-randomized, open label study to assess safety and performance of the Xeltis 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, Open Label Clinical Study to Assess the Safety and Performance of the Xeltis Pulmonary Valved Conduit in Subjects Undergoing Right Ventricular Outflow Tract (RVOT) Reconstruction

Conditions
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Heart Defects, Congenital

Intervention / Treatment
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* Device: Xeltis 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 or 18 mm valved conduit. Male or Female. Age < 22 years. Right Ventricular to Pulmonary Artery mean 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 bacterial or viral infection or requiring current antibiotic therapy (if temporary illness, patient may be a candidate 4 weeks after discontinuation of antibiotics) Active endocarditis Leukopenia, according to local laboratory evaluation of white blood cell count Acute or chronic anemia, according to local laboratory evaluation of hemoglobin Patients can be transfused to meet eligibility criteria Thrombocytopenia, defined as Platelet count < 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 (right ventricular systolic pressure ≥ 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 Patient 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 Females who are sexually active and are not willing to use adequate contraceptive precautions for the next 2 years Patient has medical, social or psychosocial factors that, in the opinion of the Investigator, could have impact on safety or compliance

Ages Eligible for Study
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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 Pulmonary Valved Conduit<br>PV Conduit for RVOT reconstruction | Device: Xeltis Pulmonary Valved Conduit<br>* RVOT reconstruction<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Survival at 12 months follow up post implantation | Measured by the fact that the patient is still alive at the time of the 12 month FU visit | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Freedom from device related death, intervention and/or reoperation at 12 months follow up | Measured by the fact that the patient did not die, did not have a reoperation or reintervention during the first 12 months | 12 months | 
| Mean pressure gradient across the area of conduit implantation (RV to PA) of less than 40 mm Hg at 12 months follow up |  | 12 months | 
| Pulmonary regurgitation of equal or less than moderate (≤40 %) at 12 months follow up |  | 12 months |