Prospective, Non-randomized, Pivotal Study to Assess the Safety and Efficacy of the Bioabsorbable Pulmonary Valved Conduit in Subjects Undergoing Right Ventricular Outflow Tract (RVOT) Reconstruction

Xeltis10 sites in 4 countries56 target enrollmentMay 8, 2017

ConditionsHeart Defect, Congenital

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Heart Defect, Congenital
Sponsor: Xeltis
Enrollment: 56
Locations: 10
Primary Endpoint: Composite rate of events of device related death, re-operation or re-intervention at 12 months follow-up.
Status: Active, not recruiting
Last Updated: 9 months ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

This is a multi-center prospective, single-arm, non-randomized, pivotal study that will continue to access the feasibility of the Xeltis Bioabsorbable Pulmonary Valved Conduit in subjects requiring right ventricular outflow tract correction or reconstruction due to congenital heart malformations.

Registry

clinicaltrials.gov

Start Date

May 8, 2017

End Date

December 1, 2026

Last Updated

9 months 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,18 mm, 20 mm and 22 mm valved conduit.
•Male or Female.
•Age \> 2 years and \< 22 years.
•Right Ventricular to Pulmonary Artery peak gradient \> 35mm Hg or moderate or severe Pulmonary regurgitation (≥3+), or have both (except for the patients undergoing a Ross procedure)
•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 infection or requiring current antibiotic therapy (if temporary illness, subject may be a candidate 4 weeks after discontinuation of antibiotics) or viral infection.
•Active endocarditis.
•Leukopenia, defined as White Blood cell Count \< than:
•2-12 years: 5.0 ×103 /μL
•12 years - Adult:
•Male: 4.5×103 /μL
•Female: 4.5 ×103 /μL

Outcomes

Primary Outcomes

Composite rate of events of device related death, re-operation or re-intervention at 12 months follow-up.

Time Frame: 12 months

Measured once all 12 month follow up visits have been completed

Secondary Outcomes

Overall rate of subjects with pulmonary regurgitation of equal or less than moderate at 6 and 12 months follow up.(6 and 12 months)
Overall rate of subjects with a mean pressure gradient across the area of conduit implantation of less than 40 mm Hg at 6 and 12 months follow up.(6 and 12 months)
Overall rate of mortality at 60 months follow up post implantation.(60 months)
Overall rate of subjects who require reoperation or re-intervention due to device failure 12 months.(12 months)
Overall rate of device related death due to device failure at 6 months follow up post implantation.(6 months)