Bioabsorbable Heart Valve for Congenital Heart Defects

(Xplore2 Trial)

Not currently recruiting at 10 trial locations

Age: < 65

Sex: Any

Trial Phase: Academic

Sponsor: Xeltis

Must not be taking: Antibiotics, Anticoagulants, Antiplatelets

Disqualifiers: Prosthetic heart valve, Pacemaker, Infection, Anemia, others

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

Compensation: Varies

Number of Visits: 7

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new heart valve that dissolves over time, designed for individuals with certain congenital heart defects. The focus is on those requiring surgery to repair or reconstruct the pathway from the heart to the lungs. The trial aims to determine if this new valve, the Xeltis Bioabsorbable Pulmonary Valved Conduit, can safely and effectively enhance heart function. Individuals with conditions like Tetralogy of Fallot or those needing a heart valve replacement might be suitable candidates, especially if they have faced related issues for an extended period. As an unphased trial, this study offers a unique opportunity to contribute to groundbreaking research that could lead to innovative treatments for heart defects.

Do I need to stop my current medications to join the trial?

The trial information does not specify if you need to stop taking your current medications. However, if you have an active infection requiring antibiotics, you must wait 4 weeks after stopping them to be eligible. It's best to discuss your specific medications with the trial team.

What prior data suggests that the Xeltis Bioabsorbable Pulmonary Valved Conduit is safe for congenital heart defect correction?

Research has shown that the Xeltis Bioabsorbable Pulmonary Valved Conduit performs well in early tests. In one study, 17 out of 18 patients did not require additional surgery within the first year, suggesting the treatment is well-tolerated. Another study found that heart function remained stable for up to two years after using the device in a preclinical setting. These results suggest the treatment could be safe and effective, but further research is needed to confirm this. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike traditional treatments for congenital heart defects, which often involve non-absorbable synthetic or homograft conduits, the Xeltis Bioabsorbable Pulmonary Valved Conduit offers a bio-absorbable, polymer-based solution. This means it gradually gets absorbed by the body, potentially reducing the need for repeat surgeries as the patient grows. Researchers are excited because this approach could minimize long-term complications and improve the quality of life for young patients by encouraging the natural tissue to grow in place of the device.

What evidence suggests that the Xeltis Bioabsorbable Pulmonary Valved Conduit is effective for congenital heart defects?

Research has shown that the Xeltis Bioabsorbable Pulmonary Valved Conduit, under study in this trial, holds promise for children with certain heart defects. In one study, 17 out of 18 children did not require additional surgery a year after receiving the valve, indicating its durability and effectiveness in the heart. Another study found that the valve performed well for up to two years. These findings suggest that this bioabsorbable valve could be a viable option for treating heart problems in young patients. ^{1 2 5 6 7}

Who Is on the Research Team?

Eliane Schutte

Principal Investigator

Xeltis Inc

Are You a Good Fit for This Trial?

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.

You are allergic to blood thinners and drugs that prevent blood clots, as well as materials used in medical devices.

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT03022708

Xeltis Bioabsorbable Pulmonary Valved Conduit Pivotal ... This is a multi-center prospective, single-arm, non-randomized, pivotal study that will continue to access the feasibility of the Xeltis Bioabsorbable ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7969645/

A Novel Restorative Pulmonary Valve Conduit The XPV, a biorestorative valved conduit, demonstrated promising early clinical outcomes in humans with 17 of 18 patients being free of reintervention at 1 ...

3. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/33984478/

Initial Clinical Trial of a Novel Pulmonary Valved Conduit We report the first clinical use of a completely bioabsorbable valved conduit (Xeltis pulmonary valve - XPV) in children.

4. eurointervention.pcronline.com eurointervention.pcronline.com/article/midterm-performance-of-a-novel-restorative-pulmonary-valved-conduit-preclinical-results

Midterm performance of a novel restorative pulmonary ... This study suggests that haemodynamic performance of a novel pulmonary valved conduit is favourable up to two years after implantation in a preclinical setting.

5. researchgate.net researchgate.net/publication/349767182_A_Novel_Restorative_Pulmonary_Valve_Conduit_Early_Outcomes_of_Two_Clinical_Trials

(PDF) A Novel Restorative Pulmonary Valve Conduit Conclusions: The XPV, a biorestorative valved conduit, demonstrated promising early clinical outcomes in humans with 17 of 18 patients being ...

6. centerwatch.com centerwatch.com/clinical-trials/listings/NCT03022708/xeltis-bioabsorbable-pulmonary-valved-conduit-pivotal-study

Xeltis Bioabsorbable Pulmonary Valved Conduit Pivotal ... This is a multi-center prospective, single-arm, non-randomized, pivotal study that will continue to access the feasibility of the Xeltis ...

7. dicardiology.com dicardiology.com/article/xeltis-begins-pivotal-trial-pulmonary-valve-grows-patient

Xeltis Begins Pivotal Trial for Pulmonary Valve That Grows ... Patient's own tissue naturally turns synthetic polymer device into living heart valves and may reduce need for re-interventions.