Xeltis Bioabsorbable Pulmonary Valved Conduit Pivotal Study

NCT03022708 | Active Not Recruiting DMC FDA Device

• 1 other identifier: XEL-CR-03
• Study Type: interventional
• Target: 56
• Locations: 4 countries
• Sites: 10

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.

Conditions

Heart Defect, Congenital

Outcome Measures

Primary Outcomes (1)

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

  Measured once all 12 month follow up visits have been completed

  12 months

Secondary Outcomes (5)

• Overall rate of device related death due to device failure at 6 months follow up post implantation.

  6 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 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 subjects with pulmonary regurgitation of equal or less than moderate at 6 and 12 months follow up.

  6 and 12 months

Other Outcomes (2)

• Measurement of growth of conduit in pediatric population measured at 6, 36, 48 and 60 months. A competent valve with increased valve diameter in age groups < 18 years in correlation with the increased body surface area.

  Up to 60 months

• Overall satisfaction of the implanting surgeon of the implantation procedure of the Bio-absorbable pulmonary valve conduit

  Day 0 - Implant

Study Arms (1)

Xeltis Bioabsorbable Pulmonary Valved Conduit

EXPERIMENTAL

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.

Device: Xeltis Bioabsorbable Pulmonary Valved Conduit

Interventions

Xeltis Bioabsorbable Pulmonary Valved Conduit DEVICE

Surgical implantation of Xeltis Bioabsorbable Pulmonary Valved Conduit

Xeltis Bioabsorbable Pulmonary Valved Conduit

Eligibility Criteria

• Age: 2 Years - 21 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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:
• years: 5.0 ×103 /μL
• years - Adult:
• Male: 4.5×103 /μL
• Female: 4.5 ×103 /μL
• Acute or chronic anemia, defined as Hemoglobin \< than:
• years 11.5 g /dl
• Male: 13 g /dl
• Female 12 g /dl
• Adult:

Sponsors & Collaborators

• Xeltis: lead

Study Sites (10)

Children's Hospital of Los Angeles

Los Angeles, California, 90027, United States

Location

Children's Hospital Colorado

Aurora, Colorado, 80045, United States

Location

Joe DiMaggio Children's Hospital

Hollywood, Florida, 33021, United States

Location

New York Presbyterian Hospital - Columbia University (Xplore1)

New York, New York, 10032, United States

Location

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, 45229, United States

Location

Children's Hospital of Pittsburgh of UPMC (Xplore1)

Pittsburgh, Pennsylvania, 15224, United States

Location

UTSW- Dallas Children's Hospital

Dallas, Texas, 75390-8835, United States

Location

Multiprofile Hospital for Active Treatment "National cardiology hospital" EAD, Department of Congenital Heart Defects Surgery

Sofia, Bulgaria

Location

Institut Jantung Negara Sdn Bhd

Kuala Lumpur, Malaysia

Location

University Children's Hospital of Cracow

Krakow, Poland

Location

Related Publications (1)

• Morales DL, Herrington C, Bacha EA, Morell VO, Prodan Z, Mroczek T, Sivalingam S, Cox M, Bennink G, Asch FM. A Novel Restorative Pulmonary Valve Conduit: Early Outcomes of Two Clinical Trials. Front Cardiovasc Med. 2021 Mar 4;7:583360. doi: 10.3389/fcvm.2020.583360. eCollection 2020.

  PMID: 33748192 DERIVED

MeSH Terms

Conditions

Heart Defects, Congenital

Condition Hierarchy (Ancestors)

Cardiovascular Abnormalities; Cardiovascular Diseases; Heart Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Eliane Schutte

  Xeltis Inc

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 10, 2017
• First Posted: January 16, 2017
• Study Start: May 8, 2017
• Primary Completion: December 15, 2022
• Study Completion (Estimated): December 1, 2026
• Last Updated: July 22, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

MY (1); US (7); BU (1); PL (1)