Status:
WITHDRAWN
Xeltis Pulmonary Valved Conduit Safety and Performance Study
Lead Sponsor:
Xeltis
Conditions:
Heart Defects, Congenital
Eligibility:
All Genders
Up to 21 years
Phase:
NA
Brief Summary
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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2026
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT03405636
Start Date
September 1 2020
End Date
October 1 2026
Last Update
April 9 2021
Active Locations (4)
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1
Gottsegen György Hungarian Institute of Cardiology, Paediatric Cardiac Centre
Budapest, Hungary, H-1096
2
Institute Jantung Negara, National Heart Institute
Kuala Lumpur, Malaysia
3
University Children's Hospital of Cracow (UCH),
Krakow, Poland, 30-663
4
Childrens Heart Centre Slovak Republic
Bratislava, Slovakia