Xeltis Bioabsorbable Pulmonary Valved Conduit Pivotal Study

Running, not enrolling · Not applicable

Conditions studied: Heart Defect, Congenital

In brief

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.

Key facts

Study ID

NCT03022708

Run by

Xeltis

People needed

6

Starts

2017-05-08

Expected to finish

2026-12-01

Last updated by the study team

2026-08-06

Who can join

Age: 2 and older, up to 21. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Children's Hospital of Los Angeles — Los Angeles, California, United States
• Children's Hospital Colorado — Aurora, Colorado, United States
• Joe DiMaggio Children's Hospital — Hollywood, Florida, United States
• New York Presbyterian Hospital - Columbia University (Xplore1) — New York, New York, United States
• Cincinnati Children's Hospital Medical Center — Cincinnati, Ohio, United States
• Children's Hospital of Pittsburgh of UPMC (Xplore1) — Pittsburgh, Pennsylvania, United States
• UTSW- Dallas Children's Hospital — Dallas, Texas, United States
• Multiprofile Hospital for Active Treatment "National cardiology hospital" EAD, Department of Congenital Heart Defects Surgery — Sofia, Bulgaria
• Institut Jantung Negara Sdn Bhd — Kuala Lumpur, Malaysia
• University Children's Hospital of Cracow — Krakow, Poland

Full record on ClinicalTrials.gov

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