Heart Defect, CongenitalXplore2NCT03022708
Xeltis Bioabsorbable Pulmonary Valved Conduit Pivotal Study
A study testing Xeltis Bioabsorbable Pulmonary Valved Conduit in people with Heart Defect, Congenital, run by Xeltis at 10 sites in 4 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 2 to 21 years
- Conditions the study is for
- Heart Defect, Congenital
- What is being tested?
- Xeltis Bioabsorbable Pulmonary Valved Conduit
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 10 sitesin 4 countries
- Study dates
- 8 May 2017to Dec 2026
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 to 21 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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.
Who cannot join
- 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:
Show all 33Show fewer
- 2-12 years: 5.0 ×103 /μL
- 12 years - Adult:
- Male: 4.5×103 /μL
- Female: 4.5 ×103 /μL
- 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
- Thrombocytopenia, defined as Platelet count < than:
- 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 (≥ half of systemic systolic pressure)
- Right ventricular outflow tract aneurysm.
- Known hypersensitivity to anticoagulants and antiplatelet drugs and to the device materials. .
- Immunocompromised patient defined as: autoimmune disease, patients receiving immunosuppressant drugs or immune stimulant drugs.
- Subject has chronic inflammatory / autoimmune disease.
- Need for emergency cardiac or vascular surgery or intervention.
- Major or progressive non-cardiac disease (liver failure, renal failure, cancer) that has a life expectancy of less than one year.
- Currently participating, or participated within the last 30 days, in an investigational drug or device study.
- 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.
- Pregnancy.
- Females who are sexually active and are not willing to use adequate contraceptive precautions for the next 2 years
- Subject has medical, social or psychosocial factors that, in the opinion of the Investigator, could impact safety or compliance.
Trial locations and contacts
10 sites in 4 countries.
10 sites in 4 countries
United States7 sites
Children's Hospital Colorado
Aurora, Colorado, 80045
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, 45229
UTSW- Dallas Children's Hospital
Dallas, Texas, 75390-8835
Joe DiMaggio Children's Hospital
Hollywood, Florida, 33021
Children's Hospital of Los Angeles
Los Angeles, California, 90027
New York Presbyterian Hospital - Columbia University (Xplore1)
New York, New York, 10032
Children's Hospital of Pittsburgh of UPMC (Xplore1)
Pittsburgh, Pennsylvania, 15224
Bulgaria1 site
Multiprofile Hospital for Active Treatment "National cardiology hospital" EAD, Department of Congenital Heart Defects Surgery
Sofia
About this study
Official title: 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
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
- Being tested
- Xeltis Bioabsorbable Pulmonary Valved Conduit
- Medical subject headings
- Heart Defects, Congenital
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Xeltis Bioabsorbable Pulmonary Valved ConduitDevice
Surgical implantation of Xeltis Bioabsorbable Pulmonary Valved Conduit
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Xeltis Bioabsorbable Pulmonary Valved Conduit |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 12 months
Secondary outcomes (5)
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
Measured: 6 months
To Assess Overall Mortality Rate at 60 Months.
Measured once all 60 month follow up visits have been completed.
Measured: 60 months post implant
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.
Measured: 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.
Measured by echography at 6 and 12 months follow up.
Measured: 6 and 12 months
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.
Measured: 6 and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jan 2017 (estimated)
- Study start8 May 2017
- Primary completion15 Dec 2022
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Heart Defect, CongenitalStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- Xeltis
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Eliane Schutte, Study director, Xeltis Inc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03022708
- Sponsor's protocol ID
- XEL-CR-03
- Acronym
- Xplore2
- Status last verified
- Jun 2026
- First submitted
- 10 Jan 2017
- Last updated
- 6 Aug 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
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 at a glance
From the registry record, last updated by the sponsor on 6 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT03022708
- Acronym / sponsor ID
- Xplore2 / XEL-CR-03
- Conditions
- Heart Defect, Congenital
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 6 participants (actual)
- Lead sponsor
- XeltisIndustry (pharma, biotech, devices)
- Study start
- 8 May 2017 (actual)
- Primary completion
- 15 Dec 2022 (actual)
- Study completion
- Dec 2026 (estimated)
- First posted
- 16 Jan 2017 (estimated)
- Results
- Posted 6 Aug 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Xeltis Bioabsorbable Pulmonary Valved Conduit | Experimental | Device: Xeltis Bioabsorbable Pulmonary Valved ConduitThe 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 may qualify
- Ages
- 2 to 21 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (33 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Xeltis Bioabsorbable Pulmonary Valved ConduitSurgical implantation of Xeltis Bioabsorbable Pulmonary Valved Conduit | Device | Xeltis Bioabsorbable Pulmonary Valved Conduit |
Primary outcome
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
5 secondary outcomes
Overall Rate of Device Related Death Due to Device Failure at 6 Months Follow up Post Implantation.
Time frame: 6 months
To Assess Overall Mortality Rate at 60 Months.
Time frame: 60 months post implant
Overall Rate of Subjects Who Require Reoperation or Re-intervention Due to Device Failure 12 Months.
Time frame: 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.
Time frame: 6 and 12 months
Overall Rate of Subjects With Pulmonary Regurgitation of Equal or Less Than Moderate at 6 and 12 Months Follow up.
Time frame: 6 and 12 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Aug 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 33748192Morales 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Eliane Schutte study director
Xeltis Inc
10 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Xeltis Bioabsorbable Pulmonary Valved Conduit in people with Heart Defect, Congenital, run by Xeltis at 10 sites in 4 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 33 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 6 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in United States, Bulgaria, Malaysia, Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 6 Aug 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Composite Rate of Events of Device Related Death, Re-operation or Re-intervention at 12 Months Follow-up. (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03022708, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Aug 2026.