Xeltis Pulmonary Valved Conduit Safety and Performance Study

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

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.

Study Overview

• Status: Withdrawn
• Conditions: Heart Defects, Congenital
• Intervention / Treatment: Device: Xeltis Pulmonary Valved Conduit

• Study Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Hungary
  • Budapest, Hungary, H-1096
    • Gottsegen György Hungarian Institute of Cardiology, Paediatric Cardiac Centre
• Malaysia
  • Kuala Lumpur, Malaysia
    • Institute Jantung Negara, National Heart Institute
• Poland
  • Krakow, Poland, 30-663
    • University Children's Hospital of Cracow (UCH),
• Slovakia
  • Bratislava, Slovakia
    • Childrens Heart Centre Slovak Republic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 21 years (ADULT, CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Xeltis Pulmonary Valved Conduit; PV Conduit for RVOT reconstruction	Device: Xeltis Pulmonary Valved Conduit; RVOT reconstruction

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
Pulmonary regurgitation of equal or less than moderate (≤40 %) at 12 months follow up		12 months

Collaborators and Investigators

• Sponsor: Xeltis

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): September 1, 2020
• Primary Completion (ANTICIPATED): October 1, 2021
• Study Completion (ANTICIPATED): October 1, 2026

Study Registration Dates

• First Submitted: January 15, 2018
• First Submitted That Met QC Criteria: January 15, 2018
• First Posted (ACTUAL): January 23, 2018

Study Record Updates

• Last Update Posted (ACTUAL): April 9, 2021
• Last Update Submitted That Met QC Criteria: April 6, 2021
• Last Verified: April 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Cardiovascular Abnormalities; Congenital Abnormalities; Heart Defects, Congenital
• Other Study ID Numbers: XEL-CR-02

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No