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

Xeltis4 sites in 4 countriesSeptember 2020

ConditionsHeart Defects, Congenital

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Heart Defects, Congenital
Sponsor: Xeltis
Locations: 4
Primary Endpoint: Survival at 12 months follow up post implantation
Status: Withdrawn
Last Updated: 5 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

September 2020

End Date

October 2026

Last Updated

5 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Xeltis

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Patient requiring RVOT reconstruction, suitable for 16 mm or 18 mm valved conduit.
•Male or Female.
•Age \< 22 years.
•Right Ventricular to Pulmonary Artery mean gradient \> 35mm Hg or moderate or severe Pulmonary regurgitation (≥3+), or have both.
•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.
•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

•Need for or presence of prosthetic heart valve at other position
•Need for concomitant surgical procedures (non-cardiac)
•Patients with previously implanted pacemaker (including defibrillators) or mechanical valves
•Active bacterial or viral infection or requiring current antibiotic therapy (if temporary illness, patient may be a candidate 4 weeks after discontinuation of antibiotics)
•Active endocarditis
•Leukopenia, according to local laboratory evaluation of white blood cell count
•Acute or chronic anemia, according to local laboratory evaluation of hemoglobin Patients can be transfused to meet eligibility criteria
•Thrombocytopenia, defined as Platelet count \< 150,000/mm3 Patients can be transfused to meet eligibility criteria
•Severe chest wall deformity, which would preclude placement of the PV conduit
•Pulmonary hypertension (right ventricular systolic pressure ≥ half of systemic systolic pressure)

Outcomes

Primary Outcomes

Survival at 12 months follow up post implantation

Time Frame: 12 months

Measured by the fact that the patient is still alive at the time of the 12 month FU visit

Secondary Outcomes

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)
Freedom from device related death, intervention and/or reoperation at 12 months follow up(12 months)