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.
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.
"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
"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
"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
"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
"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
"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
"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
"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
"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
"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
"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