Xeltis Bioabsorbable Pulmonary Valved Conduit Pivotal Study (Xplore2)

Xeltis

Status: Active, not recruiting

Conditions: Heart Defect, Congenital

Treatments: Device: Xeltis Bioabsorbable Pulmonary Valved Conduit

Study type: Interventional

Funder types: Industry

Identifiers

NCT03022708

XEL-CR-03

Details and patient eligibility

About

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.

Enrollment: 56 estimated patients

Sex: All

Ages: 2 to 21 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

56 participants in 1 patient group

Xeltis Bioabsorbable Pulmonary Valved Conduit

Experimental group

Description:

The Bioabsorbable Pulmonary Valved Conduit bio-absorbable, polymer-based medical device. The PV conduit is used in patients for correction or reconstruction of the Right Ventricular Outflow Tract (RVOT), in patients less than 22 years with any of the following congenital heart malformations: * Tetralogy of Fallot * Truncus Arteriosus * Pulmonary Atresia * Transposition of Great Arteries with Ventricular Septal Defect * Pulmonary Stenosis in combination with other defects in congenital heart defect (CHD) syndromes In addition, the PV conduit can be used for the following indications: * replacement of previously implanted, but dysfunctional, pulmonary homografts or valved conduits (except for mechanical valves, see exclusion criterion 3). * Patients undergoing a Ross procedure, where the PV conduit would replace the patient's own pulmonary valve which is used to replace a diseased aortic valve.

Treatment:

Device: Xeltis Bioabsorbable Pulmonary Valved Conduit