Xeltis Pulmonary Valved Conduit Safety and Performance Study

Heart Defects, Congenital Clinical Trial

Official title:

Prospective, Non-randomized, Open Label Clinical Study to Assess the Safety and Performance of the Xeltis Pulmonary Valved Conduit in Subjects Undergoing Right Ventricular Outflow Tract (RVOT) Reconstruction

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT03405636
• Other study ID #: XEL-CR-02
• Status: Withdrawn
• Phase: N/A
• Start date: September 2020
• Est. completion date: October 2026

Study information

• Verified date: April 2021
• Source: Xeltis
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 Tract correction or reconstruction due to congenital heart malformations.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: October 2026
• Est. primary completion date: October 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 21 Years

Eligibility

Inclusion Criteria:

1. Patient requiring RVOT reconstruction, suitable for 16 mm or 18 mm valved conduit.

2. Male or Female.

3. Age < 22 years.

4. Right Ventricular to Pulmonary Artery mean gradient > 35mm Hg or moderate or severe Pulmonary regurgitation (=3+), or have both.

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 bacterial or viral infection or requiring current antibiotic therapy (if temporary illness, patient may be a candidate 4 weeks after discontinuation of antibiotics)

5. Active endocarditis

6. Leukopenia, according to local laboratory evaluation of white blood cell count

7. Acute or chronic anemia, according to local laboratory evaluation of hemoglobin Patients can be transfused to meet eligibility criteria

8. Thrombocytopenia, defined as Platelet count < 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 (right ventricular systolic pressure = 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. Patient 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. Females who are sexually active and are not willing to use adequate contraceptive precautions for the next 2 years

20. Patient has medical, social or psychosocial factors that, in the opinion of the Investigator, could have impact on safety or compliance

Related Conditions & MeSH terms

• Congenital Abnormalities
• Heart Defects, Congenital

Intervention

Device:
• Xeltis Pulmonary Valved Conduit
RVOT reconstruction

Locations

Country	Name	City	State
Hungary	Gottsegen György Hungarian Institute of Cardiology, Paediatric Cardiac Centre	Budapest
Malaysia	Institute Jantung Negara, National Heart Institute	Kuala Lumpur
Poland	University Children's Hospital of Cracow (UCH),	Krakow
Slovakia	Childrens Heart Centre Slovak Republic	Bratislava

Sponsors (1)

Lead Sponsor	Collaborator
Xeltis

Countries where clinical trial is conducted

Hungary,  Malaysia,  Poland,  Slovakia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Survival at 12 months follow up post implantation	Measured by the fact that the patient is still alive at the time of the 12 month FU visit	12 months
Secondary	Freedom from device related death, intervention and/or reoperation at 12 months follow up	Measured by the fact that the patient did not die, did not have a reoperation or reintervention during the first 12 months	12 months
Secondary	Mean pressure gradient across the area of conduit implantation (RV to PA) of less than 40 mm Hg at 12 months follow up		12 months
Secondary	Pulmonary regurgitation of equal or less than moderate (=40 %) at 12 months follow up		12 months