Xeltis Pulmonary Valved Conduit Safety and Performance Study

NCT ID: NCT03405636

Last Updated: 2021-04-09

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-09-30
• Study Completion Date: 2026-10-31

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 Tract correction or reconstruction due to congenital heart malformations.

Conditions

Heart Defects, Congenital

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Xeltis Pulmonary Valved Conduit

PV Conduit for RVOT reconstruction

Group Type: EXPERIMENTAL

Xeltis Pulmonary Valved Conduit

Intervention Type: DEVICE

RVOT reconstruction

Interventions

Xeltis Pulmonary Valved Conduit

RVOT reconstruction

Intervention Type: DEVICE

Eligibility 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

• Maximum Eligible Age: 21 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Xeltis

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Gottsegen György Hungarian Institute of Cardiology, Paediatric Cardiac Centre

Budapest, , Hungary

Institute Jantung Negara, National Heart Institute

Kuala Lumpur, , Malaysia

University Children's Hospital of Cracow (UCH),

Krakow, , Poland

Childrens Heart Centre Slovak Republic

Bratislava, , Slovakia

Countries

Hungary; Malaysia; Poland; Slovakia

Other Identifiers

XEL-CR-02

Identifier Type: -

Identifier Source: org_study_id