Bioabsorbable Heart Valve for Congenital Heart Defects

(Xplore2 Trial)

Recruiting at 9 trial locations

Age: < 65

Sex: Any

Trial Phase: Academic

Sponsor: Xeltis

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 7

56 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Research Team

Eliane Schutte

Principal Investigator

Xeltis Inc

Eligibility Criteria

This trial is for children and young adults aged 2 to 22 with congenital heart defects needing right ventricular outflow tract correction. Participants must be able to attend follow-up visits, not have severe allergies to device materials or anticoagulants, no autoimmune diseases, no emergency surgery needs, and not pregnant or abusing substances.

Inclusion Criteria

I am either male or female.

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

I am not currently fighting an infection or on antibiotics.

My hemoglobin levels are below the normal range for my age and gender.

I have an ongoing heart infection.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Implantation

Implantation of the Bioabsorbable Pulmonary Valved Conduit

Day 0

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

60 months

Multiple visits at 6, 12, 36, 48, and 60 months

Treatment Details

Interventions

• Xeltis Bioabsorbable Pulmonary Valved Conduit

Trial Overview The study tests the Xeltis Bioabsorbable Pulmonary Valved Conduit in a single group of participants without comparing it to other treatments. It's designed to see if this new type of heart valve can help correct blood flow issues caused by congenital heart malformations.

Participant Groups

Group I: Xeltis Bioabsorbable Pulmonary Valved Conduit Experimental Treatment 1 Intervention

The Bioabsorbable Pulmonary Valved Conduit bio-absorbable, polymer-based medical device. The PV conduit is used in patients for correction or reconstruction of the Right Ventricular Outflow Tract (RVOT), in patients less than 22 years with any of the following congenital heart malformations: * Tetralogy of Fallot * Truncus Arteriosus * Pulmonary Atresia * Transposition of Great Arteries with Ventricular Septal Defect * Pulmonary Stenosis in combination with other defects in congenital heart defect (CHD) syndromes In addition, the PV conduit can be used for the following indications: * replacement of previously implanted, but dysfunctional, pulmonary homografts or valved conduits (except for mechanical valves, see exclusion criterion 3). * Patients undergoing a Ross procedure, where the PV conduit would replace the patient's own pulmonary valve which is used to replace a diseased aortic valve.

Who Is Running the Clinical Trial?

Xeltis

Lead Sponsor

Trials

10

Recruited

400+