Xeltis Pulmonary Valved Conduit Safety and Performance Study

• Register: ClinicalTrials.gov
• Last refreshed on: 19 April 2021
• Main ID: NCT03405636
• Date of registration: 15/01/2018
• Prospective Registration: Yes
• Primary sponsor: Xeltis
• Public title: Xeltis Pulmonary Valved Conduit Safety and Performance Study
• Scientific 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
• Date of first enrolment: September 2020
• Target sample size: 0
• Recruitment status: Withdrawn
• URL: https://clinicaltrials.gov/show/NCT03405636
• Study type: Interventional
• Study design: Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: N/A

Countries of recruitment

Hungary, Malaysia, Poland, Slovakia

Key inclusion & exclusion criteria

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



Age minimum: N/A
Age maximum: 21 Years
Gender: All

Health Condition(s) or Problem(s) studied

Heart Defects, Congenital

Intervention(s)

Device: Xeltis Pulmonary Valved Conduit

Primary Outcome(s)

Survival at 12 months follow up post implantation [Time Frame: 12 months]

Secondary Outcome(s)

Pulmonary regurgitation of equal or less than moderate (=40 %) at 12 months follow up [Time Frame: 12 months]

Freedom from device related death, intervention and/or reoperation at 12 months follow up [Time Frame: 12 months]

Mean pressure gradient across the area of conduit implantation (RV to PA) of less than 40 mm Hg at 12 months follow up [Time Frame: 12 months]

Secondary ID(s)

XEL-CR-02

Source(s) of Monetary Support

Please refer to primary and secondary sponsors