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
Among 356 studies in Heart Defects, Congenital with a site in United States — 66 open to participants now, 87 under way, 4 of them phase 3. Heart Defects, Congenital · United States.
Among the 356 studies in Heart Defects, Congenital with a site in United States, this one is the 163rd largest by enrollment of the 184 interventional ones that give a count, is one of 21 that started in 2017, is one of 111 with no phase, reaches primary completion later than 4 of the 86 other live ones, and was the 188th registered.
991 studies on the registry are indexed under Heart Defects, Congenital; 251 are open to participants now.
Browse Heart Defects, Congenital studies →66 of the 356 studies in Heart Defects, Congenital with a site in United States are open now. Recruiting first, the newest first:
University of Nebraska · Sites in United States
Le Bonheur Children's Hospital · Sites in United States
Carelon Research · Sites in United States
Carelon Research · Sites in United States
The Cleveland Clinic · Sites in United States
A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →
Of the 154 Heart Defects, Congenital studies recruiting now, 67 (44%) set no upper age limit and 79 (51%) stop at 75 or younger; 110 take children under 18; 25 take healthy volunteers.
This study: 2 Years to 21 Years · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
356 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 22 · Phase 2 33 · Phase 3 25 · Phase 4 9
First in 1980; this study’s year is marked. 21 started in 2017.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 6 is below the median of 60 across 507 interventional studies indexed under Heart Defects, Congenital.
Median enrollment 50 across the 184 interventional studies, 72 across the 167 observational. Of the 240 that completed or were terminated, 62 (26%) have results posted.
This tab as a report to print or save as PDF → With an account.
31 of 356 have an industry lead sponsor. The 10 most frequent:
Xeltis is the lead sponsor of 13 studies on the registry; 5 are open to participants now.
Xeltis has 5 studies filed under Heart Defects, Congenital — fewer than ten, so there is no comparison to draw.
30 of the studies in Heart Defects, Congenital with a site in United States that are under way reach primary completion within a year, 1 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT04216927Phase 3Children's Hospital Medical Center, CincinnatiNO During CPB in Neonates to Reduce Risk of AKI | 2027-06-30 |
| NCT05077774Medtronic CardiovascularHarmony TPV Post-Approval Study | 2026-11 |
| NCT05687292Boston Children's HospitalApplication of a Clinical Decision Support System to Reduce Mechanical Ventilation Duration After Cardiac Surgery in Children | 2026-11-18 |
| NCT07559253University of Wisconsin, MadisonImplementation of an Accessible Healthcare Model (ACHD STRONG): Comparing Nurse and Physician Lead Healthcare Transition Education in a RE-AIM Framework | 2026-11-30 |
| NCT04236479Catherine BollardMesenchymal Stromal Cells for Infants With Congenital Heart Disease (MedCaP) | 2026-12 |
Among the 356 studies in Heart Defects, Congenital with a site in United States, from their registry updates:
This tab as a report to print or save as PDF → With an account.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Leukopenia, defined as White Blood cell Count \< than:
Acute or chronic anemia, defined as \< than:
Thrombocytopenia, defined as count \< than:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hemoglobin (Hb)
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
Surgical implantation of Xeltis Bioabsorbable Pulmonary Valved Conduit
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
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
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
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
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
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
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
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
| Milestone | Xeltis Bioabsorbable Pulmonary Valved Conduit |
|---|---|
| Started | 6 |
| 12 month visit completed | 6 |
| Follow-up ongoing | 6 |
| Completed | 0 |
| Not completed | 6 |
Measured once all 12 month follow up visits have been completed
| Participants | Xeltis Bioabsorbable Pulmonary Valved Conduit |
|---|---|
| Composite Rate of Events of Device Related Death, Re-operation or Re-intervention at 12 Months Follow-up. | 0 |
Measured once all 6 month follow up visits have been completed
| Participants | Xeltis Bioabsorbable Pulmonary Valved Conduit |
|---|---|
| Overall Rate of Device Related Death Due to Device Failure at 6 Months Follow up Post Implantation. | 0 |
Measured once all 60 month follow up visits have been completed.
Results for this outcome have not been posted.
Measured once all 12 month follow up visits have been completed.
| Participants | Xeltis Bioabsorbable Pulmonary Valved Conduit |
|---|---|
| Overall Rate of Subjects Who Require Reoperation or Re-intervention Due to Device Failure 12 Months. | 0 |
Measured with echocardiography at 6, 36, 48 and 60 months follow up.
Results for this outcome have not been posted.
Measured by echography at 6 and 12 months follow up.
| Participants | Xeltis Bioabsorbable Pulmonary Valved Conduit |
|---|---|
| at 6 months — Mean pressure gradient of less than 40 mm Hg | 5 |
| at 6 months — Mean pressure gradient of more than 40 mm Hg | 0 |
| at 6 months — Not assessable | 1 |
| at 12 months — Mean pressure gradient of less than 40 mm Hg | 5 |
| at 12 months — Mean pressure gradient of more than 40 mm Hg | 0 |
| at 12 months — Not assessable | 1 |
Measured by echography at 6 and 12 months follow up.
| Participants | Xeltis Bioabsorbable Pulmonary Valved Conduit |
|---|---|
| at 6 months — Equal or less than moderate pulmonary regurgitation | 5 |
| at 6 months — More than moderate pulmonary regurgitation | 0 |
| at 6 months — Not assessable | 1 |
| at 12 months — Equal or less than moderate pulmonary regurgitation | 5 |
| at 12 months — More than moderate pulmonary regurgitation | 0 |
| at 12 months — Not assessable | 1 |
Measured with a questionnaire given to the implanting surgeon at the time of implantation of the pulmonary valve conduit.
Results for this outcome have not been posted.
Collected over From implant to 12 months follow-up. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Xeltis Bioabsorbable Pulmonary Valved Conduit | 0/6 (0%) | 1/6 (16.7%) | 3/6 (50%) |
| Event | Xeltis Bioabsorbable Pulmonary Valved Conduit |
|---|---|
| PneumoniaRespiratory, thoracic and mediastinal disorders | 1/6 |
| Event | Xeltis Bioabsorbable Pulmonary Valved Conduit |
|---|---|
| Junctional rhythmCardiac disorders | 1/6 |
| RhinovirusRespiratory, thoracic and mediastinal disorders | 1/6 |
| Enterovirus infectionInfections and infestations | 1/6 |
| AnemiaBlood and lymphatic system disorders | 1/6 |
| Possible localized thrombusBlood and lymphatic system disorders | 1/6 |
| CoughGeneral disorders | 1/6 |
| Mild PV StenosisCardiac disorders | 1/6 |
| Age, Continuous(Years) | Xeltis Bioabsorbable Pulmonary Valved Conduit |
|---|---|
| Mean | 6.5 ± 3.0 |
| Sex: Female, Male(Participants) | Xeltis Bioabsorbable Pulmonary Valved Conduit |
|---|---|
| Female | 4 |
| Male | 2 |
| Race/Ethnicity, Customized(Participants) | Xeltis Bioabsorbable Pulmonary Valved Conduit |
|---|---|
| Race — White | 5 |
| Race — Black or African American | 1 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
Ran from May 2017 to primary completion in Dec 2022, 67 months.
Results were first posted in Aug 2026, 3 years 7 months after primary completion.
Of 223 interventional studies with no phase under Heart Defects, Congenital, half reached primary completion within 34 months of starting (the median), counting those still running; a quarter within 17 and three quarters within 57. This study's 67 months is above that.
How these figures are worked out, and which studies are left out of them.
This study is active, not recruiting, as verified in Jun 2026. You cannot join it, but the record below documents what was studied.
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