Heart Defect, Congenital
Conditions
Brief summary
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.
Interventions
DEVICEXeltis Bioabsorbable Pulmonary Valved Conduit
Surgical implantation of Xeltis Bioabsorbable Pulmonary Valved Conduit
Sponsors
Xeltis
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
2 Years to 21 Years
Healthy volunteers
No
Inclusion criteria
1. Patient requiring RVOT reconstruction, suitable for 16 mm,18 mm, 20 mm and 22 mm valved conduit. 2. Male or Female. 3. Age \> 2 years and \< 22 years. 4. 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) 5. 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. 6. 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
1. Need for or presence of prosthetic heart valve at other position. 2. Need for concomitant surgical procedures (non-cardiac). 3. Patients with previously implanted pacemaker (including defibrillators), or mechanical valves. 4. Active infection or requiring current antibiotic therapy (if temporary illness, subject may be a candidate 4 weeks after discontinuation of antibiotics) or viral infection. 5. Active endocarditis. 6. 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 7. 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 8. Thrombocytopenia, defined as Platelet count \< than: * 150,000/mm3 Patients can be transfused to meet eligibility criteria 9. Severe chest wall deformity, which would preclude placement of the PV conduit. 10. Pulmonary hypertension (≥ half of systemic systolic pressure) 11. Right ventricular outflow tract aneurysm. 12. Known hypersensitivity to anticoagulants and antiplatelet drugs and to the device materials. . 13. Immunocompromised patient defined as: autoimmune disease, patients receiving immunosuppressant drugs or immune stimulant drugs. 14. Subject has chronic inflammatory / autoimmune disease. 15. Need for emergency cardiac or vascular surgery or intervention. 16. Major or progressive non-cardiac disease (liver failure, renal failure, cancer) that has a life expectancy of less than one year. 17. Currently participating, or participated within the last 30 days, in an investigational drug or device study. 18. 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. 19. Pregnancy. 20. Females who are sexually active and are not willing to use adequate contraceptive precautions for the next 2 years 21. Subject has medical, social or psychosocial factors that, in the opinion of the Investigator, could impact safety or compliance.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Composite Rate of Events of Device Related Death, Re-operation or Re-intervention at 12 Months Follow-up. | 12 months | Measured once all 12 month follow up visits have been completed |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Overall Rate of Device Related Death Due to Device Failure at 6 Months Follow up Post Implantation. | 6 months | Measured once all 6 month follow up visits have been completed |
| To Assess Overall Mortality Rate at 60 Months. | 60 months post implant | Measured once all 60 month follow up visits have been completed. |
| Overall Rate of Subjects Who Require Reoperation or Re-intervention Due to Device Failure 12 Months. | 12 months | Measured once all 12 month follow up visits have been completed. |
| 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. | 6 and 12 months | Measured by echography at 6 and 12 months follow up. |
| Overall Rate of Subjects With Pulmonary Regurgitation of Equal or Less Than Moderate at 6 and 12 Months Follow up. | 6 and 12 months | Measured by echography at 6 and 12 months follow up. |
Countries
Bulgaria, Malaysia, Poland, United States
Contacts
STUDY_DIRECTOREliane Schutte
Xeltis Inc
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous | 6.5 Years STANDARD_DEVIATION 3 |
| Race/Ethnicity, Customized Race Black or African American | 1 Participants |
| Race/Ethnicity, Customized Race White | 5 Participants |
| Sex: Female, Male Female | 4 Participants |
| Sex: Female, Male Male | 2 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 6 |
| other Total, other adverse events | 3 / 6 |
| serious Total, serious adverse events | 1 / 6 |
Outcome results
None listed