XPLORE2/PIVOTAL IS AN FDA-APPROVED CLINICAL RESEARCH STUDY ON A NOVEL, RESTORATIVE PULMONARY HEART VALVE
The Xplore2/Pivotal study aims to demonstrate the clinical safety and efficacy of the Xeltis restorative pulmonary heart valve device in patients requiring Right Ventricular Outflow Tract (RVOT) reconstruction, due to congenital heart defects (CHD).
The Xplore2/Pivotal trial is actively enrolling patients.
Enrolling hospitals
Xplore2/Pivotal is a clinical research study on an investigational device not approved for use outside of clinical trials in the US, EU and Asia.
WHO NEEDS A PULMONARY HEART VALVE REPLACEMENT?
Congenital Heart Disease (CHD) is the most common type of birth defects.
One in 100 babies are born with a heart defect in the USA affecting about 40,000 infants each year.
Over 1 million adults are living with congenital heart defects.
Generally, 15-20 percent of CHDs affect the Right Ventricular Outflow Tract (RVOT).
These defects reduce or stop the blood flowing to their pulmonary arteries and include severe conditions, such as:
Defective RVOTs require a surgical intervention called RVOT reconstruction, which normally involves the replacement of the pulmonary valve.
CURRENT PULMONARY HEART VALVE DEVICES
Today, pulmonary valve replacement devices are generally made from animal tissue (biological valves), from artificial materials (mechanical valves) or come from human donors (homografts).
They are lifesavers but they may be generally short-lived.
The long-term presence of a valve replacement device in the heart generally triggers inflammation that may result in complications, including:
- Calcification of the valve, due to build-up of minerals that makes the leaflets stiff
- Stenosis or narrowing of the valve because tissue forms around it
Some devices require life-long anticoagulation therapy, with potentially severe side effects
Valves from donors may require a long wait
As such, patients may need to undergo a number of subsequent pulmonary valve replacements throughout their lives.
A NOVEL, RESTORATIVE PULMONARY VALVE
Xeltis developed a novel restorative pulmonary valve device to enable the body to naturally restore a new, living heart valve with patient’s own tissue.
Xeltis’ restorative pulmonary valve is made of polymers, a type of synthetic materials.
IMPLANTATION
Its very porous micro-structure allows patients cells to use it as a home to form new tissue.
NEOTISSUE FORMATION
As new tissue forms, it naturally turns Xeltis implant into a new, living heart valve that gradually takes over functionality.
FUNCTIONAL RESTORATION
Meanwhile, the original implant gradually absorbs in the body.
This is a novel therapeutic approach called Endogenous Tissue Restoration, or ETR.
Xeltis’ bio-restorative polymer technology is based on Nobel prize awarded science.
RESULTS TO DATE
To date, 18 patients have been successfully implanted with Xeltis’ restorative pulmonary valves in the USA, Europe and Asia, as part of the Xplore-1 First-In-Human and Xplore-2 FDA Early Feasibility studies.
Patients have been carefully followed-up and evidence from more than 60 patient/years confirmed the positive safety profile of this novel technology.
Results from existing trials on Xeltis’ restorative technology have been published in peer-reviewed publications:
- Morales D et al. Restorative pulmonary valve, one and two-year results in patients. Frontiers in Cardiovascular Medicine
- Bennink G et al. Restorative pulmonary valve in preclinical studies. The Journal of Thoracic and Cardiovascular Surgery
- Jewell C. Synthetic valves in one-year animal studies. Science Translational Medicine
- Webber M et al. Supramolecular biomaterials. Nature Materials
STUDY OVERVIEW
50Patients
Patients aged 2-21 years old requiring RVOT reconstruction *
*Inclusion and exclusion criteria apply
Up to15sites in USA, Europe, Asia
Principal Investigator: Dr David Morales – Cincinnati Children’s Hospital Medical Center
XPLORE2/PIVOTAL ENROLLING CENTERS
Please contact the relevant trial centers for any enquiries.
XELTIS is the medical device company sponsoring the Xplore2/Pivotal study.
PLEASE NOTE: XELTIS CANNOT PROVIDE ANY INFORMATION TO INDIVIDUAL PATIENTS IN RELATIONS TO CLINICAL TRIALS, DUE TO PRIVACY AND CLINICAL PRACTICE REGULATIONS.
Why participate in a clinical trial?
Clinical trials are research studies conducted in carefully selected people to evaluate a medical or surgical intervention. They help researchers learn more about a new treatment, such as a medical device.
BENEFITS
CONCERNS
For full study information and details please visit:
clinicaltrials.gov Study Number NCT03022708
or contact your clinician.
To learn more about Xeltis the study sponsor, please visit: xeltis.com
Xplore2/Pivotal is a clinical research study on an investigational device not approved for use outside of clinical trials in the US, EU and Asia.
