Heart Defect, Congenital
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 ConduitSurgical implantation of Xeltis Bioabsorbable Pulmonary Valved Conduit
|Ages eligible for Study||2 Years to 21 Years|
|Genders eligible for Study||All|
|Accepts Healthy Volunteers||No|
- 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.
- 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
- Male: 13 g /dl
- Female 12 g /dl
- 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.
- 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.
United States (4)
- Children's Healthcare of AtlantarecruitingAtlanta, Georgia, United States, 30322
- Boston Children's HospitalrecruitingBoston, Massachusetts, United States, 02115
- New York Presbyterian Hospital - Columbia UniversityrecruitingNew York, New York, United States, 10032
- The Children's Hospital of PhiladelphiarecruitingPhiladelphia, Pennsylvania, United States, 19104
07 May, 2017
21 September, 2017