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Active, not recruitingNCT03022708Xplore2Updated Aug 6, 2026Results posted

Xeltis Bioabsorbable Pulmonary Valved Conduit Pivotal Study

An interventional study of Xeltis Bioabsorbable Pulmonary Valved Conduit in Heart Defect, Congenital, sponsored by Xeltis. Active, not recruiting at 10 sites in 4 countries. Open to participants aged 2 Years to 21 Years. Per ClinicalTrials.gov, last updated 2026-08-06.

Sponsored by Xeltis · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
6
Allocation
Not applicable
Ages
2 Years to 21 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Heart Defect, Congenital
03

Who can participate

Ages eligible
2 Years to 21 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  1. Patient requiring RVOT reconstruction, suitable for 16 mm,18 mm, 20 mm and 22 mm valved conduit.
  2. Male or Female.
  3. Age > 2 years and \< 22 years.
  4. 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)
  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

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 infection or requiring current antibiotic therapy (if temporary illness, subject may be a candidate 4 weeks after discontinuation of antibiotics) or viral infection.
  5. Active endocarditis.

  6. 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

  7. Acute or chronic anemia, defined as Hemoglobin \< than:

    • 2-12 years 11.5 g /dl
    • 12-18:
    • Male: 13 g /dl
    • Female 12 g /dl
    • Adult:
    • Male: 13.5 g /dl
    • Female: 12 g /dl Patients can be transfused to meet eligibility criteria

  8. Thrombocytopenia, defined as Platelet count \< than:

    • 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 (≥ 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. Subject 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. Pregnancy.
  20. Females who are sexually active and are not willing to use adequate contraceptive precautions for the next 2 years
  21. Subject has medical, social or psychosocial factors that, in the opinion of the Investigator, could impact safety or compliance.
04

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
6 participants (actual)

Study arms

  • Experimental
    Xeltis Bioabsorbable Pulmonary Valved Conduit

    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

  • DeviceXeltis Bioabsorbable Pulmonary Valved Conduit

    Surgical implantation of Xeltis Bioabsorbable Pulmonary Valved Conduit

05

What researchers measure

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

    Time frame: 12 months

Secondary outcomes

  1. Overall Rate of Device Related Death Due to Device Failure at 6 Months Follow up Post Implantation.

    Measured once all 6 month follow up visits have been completed

    Time frame: 6 months

  2. To Assess Overall Mortality Rate at 60 Months.

    Measured once all 60 month follow up visits have been completed.

    Time frame: 60 months post implant

  3. Overall Rate of Subjects Who Require Reoperation or Re-intervention Due to Device Failure 12 Months.

    Measured once all 12 month follow up visits have been completed.

    Time frame: 12 months

  4. 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.

    Measured by echography at 6 and 12 months follow up.

    Time frame: 6 and 12 months

  5. Overall Rate of Subjects With Pulmonary Regurgitation of Equal or Less Than Moderate at 6 and 12 Months Follow up.

    Measured by echography at 6 and 12 months follow up.

    Time frame: 6 and 12 months

Other outcomes

  1. 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.

    Measured with echocardiography at 6, 36, 48 and 60 months follow up.

    Time frame: Up to 60 months

  2. Overall Satisfaction of the Implanting Surgeon of the Implantation Procedure of the Bio-absorbable Pulmonary Valve Conduit.

    Measured with a questionnaire given to the implanting surgeon at the time of implantation of the pulmonary valve conduit.

    Time frame: Day 0 - Implant

06

Results

Posted Aug 6, 2026

Participant flow

Participant flow — Overall Study
MilestoneXeltis Bioabsorbable Pulmonary Valved Conduit
Started6
12 month visit completed6
Follow-up ongoing6
Completed0
Not completed6

Outcome measures

PrimaryComposite 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

Time frame:
12 months
Reported as:
Count of participants · Participants
Composite Rate of Events of Device Related Death, Re-operation or Re-intervention at 12 Months Follow-up.
ParticipantsXeltis Bioabsorbable Pulmonary Valved Conduit
Composite Rate of Events of Device Related Death, Re-operation or Re-intervention at 12 Months Follow-up.0
SecondaryOverall Rate of Device Related Death Due to Device Failure at 6 Months Follow up Post Implantation.

Measured once all 6 month follow up visits have been completed

Time frame:
6 months
Reported as:
Count of participants · Participants
Overall Rate of Device Related Death Due to Device Failure at 6 Months Follow up Post Implantation.
ParticipantsXeltis Bioabsorbable Pulmonary Valved Conduit
Overall Rate of Device Related Death Due to Device Failure at 6 Months Follow up Post Implantation.0
SecondaryTo Assess Overall Mortality Rate at 60 Months.

Measured once all 60 month follow up visits have been completed.

Time frame:
60 months post implant

Results for this outcome have not been posted.

SecondaryOverall Rate of Subjects Who Require Reoperation or Re-intervention Due to Device Failure 12 Months.

Measured once all 12 month follow up visits have been completed.

Time frame:
12 months
Reported as:
Count of participants · Participants
Overall Rate of Subjects Who Require Reoperation or Re-intervention Due to Device Failure 12 Months.
ParticipantsXeltis Bioabsorbable Pulmonary Valved Conduit
Overall Rate of Subjects Who Require Reoperation or Re-intervention Due to Device Failure 12 Months.0
Other pre-specifiedMeasurement 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.

Measured with echocardiography at 6, 36, 48 and 60 months follow up.

Time frame:
Up to 60 months

Results for this outcome have not been posted.

SecondaryOverall 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.

Measured by echography at 6 and 12 months follow up.

Time frame:
6 and 12 months
Reported as:
Count of participants · Participants
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.
ParticipantsXeltis Bioabsorbable Pulmonary Valved Conduit
at 6 months — Mean pressure gradient of less than 40 mm Hg5
at 6 months — Mean pressure gradient of more than 40 mm Hg0
at 6 months — Not assessable1
at 12 months — Mean pressure gradient of less than 40 mm Hg5
at 12 months — Mean pressure gradient of more than 40 mm Hg0
at 12 months — Not assessable1
SecondaryOverall Rate of Subjects With Pulmonary Regurgitation of Equal or Less Than Moderate at 6 and 12 Months Follow up.

Measured by echography at 6 and 12 months follow up.

Time frame:
6 and 12 months
Reported as:
Count of participants · Participants
Overall Rate of Subjects With Pulmonary Regurgitation of Equal or Less Than Moderate at 6 and 12 Months Follow up.
ParticipantsXeltis Bioabsorbable Pulmonary Valved Conduit
at 6 months — Equal or less than moderate pulmonary regurgitation5
at 6 months — More than moderate pulmonary regurgitation0
at 6 months — Not assessable1
at 12 months — Equal or less than moderate pulmonary regurgitation5
at 12 months — More than moderate pulmonary regurgitation0
at 12 months — Not assessable1
Other pre-specifiedOverall Satisfaction of the Implanting Surgeon of the Implantation Procedure of the Bio-absorbable Pulmonary Valve Conduit.

Measured with a questionnaire given to the implanting surgeon at the time of implantation of the pulmonary valve conduit.

Time frame:
Day 0 - Implant

Results for this outcome have not been posted.

Adverse events

Collected over From implant to 12 months follow-up. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Xeltis Bioabsorbable Pulmonary Valved Conduit0/6 (0%)1/6 (16.7%)3/6 (50%)
Most frequent serious events
Most frequent serious events
EventXeltis Bioabsorbable Pulmonary Valved Conduit
PneumoniaRespiratory, thoracic and mediastinal disorders1/6
Most frequent other events
Most frequent other events
EventXeltis Bioabsorbable Pulmonary Valved Conduit
Junctional rhythmCardiac disorders1/6
RhinovirusRespiratory, thoracic and mediastinal disorders1/6
Enterovirus infectionInfections and infestations1/6
AnemiaBlood and lymphatic system disorders1/6
Possible localized thrombusBlood and lymphatic system disorders1/6
CoughGeneral disorders1/6
Mild PV StenosisCardiac disorders1/6

Baseline characteristics

Age, Continuous
Age, Continuous(Years)Xeltis Bioabsorbable Pulmonary Valved Conduit
Mean6.5 ± 3.0
Sex: Female, Male
Sex: Female, Male(Participants)Xeltis Bioabsorbable Pulmonary Valved Conduit
Female4
Male2
Race/Ethnicity, Customized
Race/Ethnicity, Customized(Participants)Xeltis Bioabsorbable Pulmonary Valved Conduit
Race — White5
Race — Black or African American1
07

Study locations

10 sites
  • Children's Hospital of Los Angeles
    Los Angeles, California 90027, United States
  • Children's Hospital Colorado
    Aurora, Colorado 80045, United States
  • Joe DiMaggio Children's Hospital
    Hollywood, Florida 33021, United States
  • New York Presbyterian Hospital - Columbia University (Xplore1)
    New York, New York 10032, United States
  • Cincinnati Children's Hospital Medical Center
    Cincinnati, Ohio 45229, United States
  • Children's Hospital of Pittsburgh of UPMC (Xplore1)
    Pittsburgh, Pennsylvania 15224, United States
  • UTSW- Dallas Children's Hospital
    Dallas, Texas 75390-8835, United States
  • Multiprofile Hospital for Active Treatment "National cardiology hospital" EAD, Department of Congenital Heart Defects Surgery
    Sofia, Bulgaria
  • Institut Jantung Negara Sdn Bhd
    Kuala Lumpur, Malaysia
  • University Children's Hospital of Cracow
    Krakow, Poland
08

References and documents

Publications

  • 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. PubMed 33748192 ↗

Study documents

  • Study protocol · May 26, 2021
  • Statistical analysis plan · Jul 15, 2021

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: No

09

Registry details

Key details

Study ID
NCT03022708
Lead sponsor
Xeltis
Responsible party
Sponsor
First posted
Jan 16, 2017
Start date
May 8, 2017
Primary completion
Dec 15, 2022
Completion
Dec 2026 (estimated)
Results posted
Aug 6, 2026
Last update
Aug 6, 2026

Study contacts

Eliane Schutte
study director · Xeltis Inc

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

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