Xplore-2 is an FDA-approved clinical research study on a novel, restorative Pulmonary Heart Valve: a device used to help improve blood flow from the heart to the lungs. Xplore-2 is a clinical research study on an investigational device not approved for use in the USA.
The study is actively recruiting and seeking eligible candidates.
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WHY DO WE NEED A NEW PULMONARY HEART VALVE?
Every year in the USA, approximately 40,000 children are born with congenital heart defects (CHDs). Approximately 15-20 percent of these children have congenital defects of the Right Ventricular Outflow Tract (RVOT) that disrupt blood flow to the pulmonary arteries. Defective RVOTs require a surgical intervention called RVOT reconstruction, which includes the replacement of the pulmonary valve.
- Calcification of the valve: build-up of minerals, leading to stiff leaflets
- Stenosis of the valve: tissue formation on the valve, leading to its narrowing.
Both situations reduce blood flow.
As a result, many currently available options for pulmonary valve replacements will need to be replaced as the child grows, and often more than one additional valve replacement will be required.
A novel, restorative pulmonary valve
To address these limitations, a novel generation of restorative heart valves have been developed and are currently under clinical investigation.
They are designed to enable the body to naturally restore a new heart valve with patient's own tissue through a novel therapeutic approach called Endogenous Tissue Restoration (ETR).
The ETR approach concept is based on the fact that a patient's healing system naturally develops tissue that can fill the porous structure of the restorative valve, forming a novel and fully functional valve within it. As ETR occurs, the restorative implants are designed to gradually absorb in the body.
WHO CAN PARTICIPATE IN THE STUDY?
The Xplore-2 study is actively recruiting patients in leading pediatric cardiac centers in the USA.
For further information on the study please visit the Contacts Page.
Patients aged between 2 and 21 years with any of the following CHDs, who fulfil all study criteria, may be eligible to participate:
- Tetralogy of Fallot (TOF)
- Truncus Arteriosus (TA)
- Pulmonary Atresia (PA)
- Transposition of Great Arteries (TGA) with Ventricular Septal Defect (VSD)
- Pulmonary Stenosis (PS) in combination with other CHD syndromes
In addition, patients who need replacement of previously implanted, but dysfunctional, pulmonary valves or a Ross procedure may also be eligible to participate. Individual patient eligibility will be determined by the clinical team of each participating site.
Patients can only be enrolled in the study, if they meet the eligible criteria and have signed an informed consent.
What happens once enrolled in the study?
The new Xeltis pulmonary valve will be implanted during standard of care surgery, as for any other currently available pulmonary heart valve replacement.
Study requirements and follow-up visits can be further discussed with the enrolling centers.
What are the potential benefits of the Xeltis restorative pulmonary valve?
- Reduced calcification and stenosis which normally cause complications
- Reduced risk of re-interventions
- Reduced risks of potential disease associated with other clinically available options
The benefits of the novel restorative heart valve can be reasonably expected; however, they cannot be guaranteed. Even if the intended clinical benefit from taking part in the study does not happen, the results may add to the understanding of new ways to treat the condition. The knowledge gained from this study may therefore also benefit other patients in the future.
What may be the risks
Most of the risks associated with this research study are the same risks associated to any similar surgery for pulmonary heart valve replacement, independently of the device used.
There may be unforeseeable risks associated with the device and participation in this study. This is because the data available or experience with the Xeltis pulmonary valve are limited.