Xeltis Bioabsorbable Pulmonary Valved Conduit for Heart Defects, Congenital

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Joe DiMaggio Children's Hospital, Hollywood, FL
Heart Defects, Congenital+2 More
Xeltis Bioabsorbable Pulmonary Valved Conduit - Device
Eligibility
< 65
All Sexes
Eligible conditions
Select

Study Summary

This study is evaluating whether a new type of heart valve can be used to treat congenital heart defects.

See full description

Eligible Conditions

  • Heart Defects, Congenital
  • Heart Defects,Congenital

Treatment Effectiveness

Effectiveness Progress

1 of 3

Other trials for Heart Defects, Congenital

Study Objectives

This trial is evaluating whether Xeltis Bioabsorbable Pulmonary Valved Conduit will improve 1 primary outcome, 5 secondary outcomes, and 2 other outcomes in patients with Heart Defects, Congenital. Measurement will happen over the course of Day 0 - Implant.

12 months
Composite rate of events of device related death, re-operation or re-intervention at 12 months follow-up.
Overall rate of subjects who require reoperation or re-intervention due to device failure 12 months.
6 and 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.
Overall rate of subjects with pulmonary regurgitation of equal or less than moderate at 6 and 12 months follow up.
6 months
Overall rate of device related death due to device failure at 6 months follow up post implantation.
60 months
Overall rate of mortality at 60 months follow up post implantation.
Day 0 - Implant
Overall satisfaction of the implanting surgeon of the implantation procedure of the Bio-absorbable pulmonary valve conduit
Up to 60 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.

Trial Safety

Safety Progress

1 of 3

Other trials for Heart Defects, Congenital

Trial Design

1 Treatment Group

Xeltis Bioabsorbable Pulmonary Valved Conduit
1 of 1
Experimental Treatment

This trial requires 56 total participants across 1 different treatment group

This trial involves a single treatment. Xeltis Bioabsorbable Pulmonary Valved Conduit is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are not being studied for commercial purposes.

Xeltis Bioabsorbable Pulmonary Valved Conduit
Device
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.

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 6 and 12 months
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly 6 and 12 months for reporting.

Closest Location

Joe DiMaggio Children's Hospital - Hollywood, FL

Eligibility Criteria

This trial is for patients born any sex aged 65 and younger. There are 6 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
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.

Patient Q&A Section

How many people get fetal anomalies a year in the United States?

"An estimated 18,000 miscarriages and 1.9 cases per 100,000 live births are attributable to some form of fetal abnormality. A more frequent screening may be required if women are counseled that a possible fetal anomaly has a 5% probability or higher of occurring." - Anonymous Online Contributor

Unverified Answer

What causes fetal anomalies?

"Significant risk is associated with maternal diabetes, maternal smoking, and prior fetal anomalies. Future work should explore the role of other infectious, chemical, behavioral, and genetic factors." - Anonymous Online Contributor

Unverified Answer

What are the signs of fetal anomalies?

"The signs of fetal anomalies vary between anomalies. Those which are more severe in the early part of pregnancy or in the fetus may be more readily identifiable as early pregnancy scans include an ultrasound for fetal structure or growth. Most other signs of fetal anomalies are found in the late part of the pregnancy or are found only if there is a suspicion of a fatal anomaly. In the absence of indications for the use of ultrasound for fetal structure, fetal death or abnormality, and in the absence in the right time in the uterus, blood tests may be the only option. A low level of amniotic fluid during late pregnancy or in labor may be an indication of a possible fetal aneuploidy." - Anonymous Online Contributor

Unverified Answer

What are common treatments for fetal anomalies?

"A large number of interventions for fetal anomalies are proposed by different sources and vary based on the country and hospital where each procedure takes place. In terms of common treatments for those affected or who give birth to infants with fetal anomalies, there are few similarities across different countries (only 12 of 74 cases). Further prospective multicentric studies are required to enable an accurate and objective evaluation of the most commonly used interventions in order to develop recommendations for these interventions." - Anonymous Online Contributor

Unverified Answer

What is fetal anomalies?

"Fetal anomalies are uncommon in the general US population. They are most common in high-risk pregnancies, which comprise 10.2% of all ART and 40% of all twinning pregnancies. They are most prevalent in multiple gestation and those arising from ICSI." - Anonymous Online Contributor

Unverified Answer

Can fetal anomalies be cured?

"Currently there is no cure for fetal anomalies. Prenatal diagnosis can detect most major anomalies before birth by ultrasound or MRI. Many fetal aneuploidies can be detected before birth using biochemical techniques, which eliminates the need for an abortion. With early diagnosis and prompt medical and surgical intervention, patients and their families can expect substantial improvement in the quality of life of affected fetuses/newborns." - Anonymous Online Contributor

Unverified Answer

Is xeltis bioabsorbable pulmonary valved conduit safe for people?

"Xeltis bioprosthesis was proven to be biocompatible and was durable in people with pulmonary valve disease. Use of this device was associated with prolonged survival and the absence of significant reoperation requirement." - Anonymous Online Contributor

Unverified Answer

Who should consider clinical trials for fetal anomalies?

"Fetal anomalies can produce a variety of clinical and imaging findings that resemble those of normal fetuses. Clinical trials have shown some potential of promising results based on limited data. However, the number of patients, the duration of follow-up, and the study group remain limitations in these trials (e.g., limited by study groups). Therefore, at this point in time, it is prudent to consult a clinician with expertise in the subject and/or in the field of fetal medicine to choose the best study for you and your family. And if a specific trial would be right for your pregnant patient, discuss with your clinician of the risks if you should/should not participate in the trial." - Anonymous Online Contributor

Unverified Answer

Does xeltis bioabsorbable pulmonary valved conduit improve quality of life for those with fetal anomalies?

"XELV did not have an effect on quality-of-life scores in this study. No difference was detected between XELV and the conventional valve group. However, patients in the XELV group reported slightly lower quality of life scores on several measures." - Anonymous Online Contributor

Unverified Answer

What is xeltis bioabsorbable pulmonary valved conduit?

"The valve is bioprosthetic and made from a synthetic polymer. After implantation, the valve is completely resorbable because of resorption of the polymer and biocompatibute substances. The volume at the proximal anastomosis decreases rapidly after implantation and the valve remains open. The valve's main use is the replacement of the pulmonary valve." - Anonymous Online Contributor

Unverified Answer

What is the average age someone gets fetal anomalies?

"It's hard to state that at what age the probability and severity increase, but we can be pretty sure that there are many cases when there is a wide variation between the number and type of anomalies, depending on the severity and the person's overall health. We can offer only partial explanations, because for the reasons that we mentioned, we cannot pinpoint them precisely. We can say that a case of severe anomalies in a young man without health problems is not a good explanation. There are many cases of less severe anomalies in a frail woman, who fortunately survived her pregnancy, without any problems. Findings from a recent study is mainly based on cases of severe anomalies; we can be convinced that the mean age of these anomalies is quite low, around 30 years." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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