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Bioabsorbable Conduit
Bioabsorbable Heart Valve for Congenital Heart Defects (Xplore2 Trial)
N/A
Waitlist Available
Research Sponsored by Xeltis
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Patient requiring RVOT reconstruction, suitable for 16 mm,18 mm, 20 mm and 22 mm valved conduit
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)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 and 12 months
Awards & highlights
Xplore2 Trial Summary
This trial will study a new type of valve for people with congenital heart malformations. The goal is to see if it is feasible and safe.
Who is the study for?
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.Check my eligibility
What is being tested?
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.See study design
What are the potential side effects?
Potential side effects may include reactions related to the body absorbing the conduit material over time, complications from surgical implantation like infection or bleeding, and possible allergic responses if sensitivity to device materials exists.
Xplore2 Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I need a procedure to repair the outflow tract from my right ventricle.
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My heart has a high pressure gradient or severe valve leakage, or both.
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I am between 2 and 22 years old.
Xplore2 Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 6 and 12 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 and 12 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Repeat Surgery
Secondary outcome measures
Overall rate of device related death due to device failure at 6 months follow up post implantation.
Overall rate of mortality at 60 months follow up post implantation.
Overall rate of subjects who require reoperation or re-intervention due to device failure 12 months.
+2 moreOther outcome measures
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.
Overall satisfaction of the implanting surgeon of the implantation procedure of the Bio-absorbable pulmonary valve conduit
Xplore2 Trial Design
1Treatment groups
Experimental Treatment
Group I: Xeltis Bioabsorbable Pulmonary Valved ConduitExperimental Treatment1 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.
Find a Location
Who is running the clinical trial?
XeltisLead Sponsor
8 Previous Clinical Trials
187 Total Patients Enrolled
Eliane SchutteStudy DirectorXeltis Inc
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am not currently fighting an infection or on antibiotics.My hemoglobin levels are below the normal range for my age and gender.I am either male or female.I have an ongoing heart infection.My platelet count is below 150,000/mm3, but I can receive a transfusion to qualify.My lung blood pressure is half or more of my body's blood pressure.I have an aneurysm in the right side of my heart.You are allergic to blood thinners and drugs that prevent blood clots, as well as materials used in medical devices.I have an autoimmune disease or am taking drugs that affect my immune system.I need emergency heart or blood vessel surgery.You have a history of alcohol or drug abuse, including using illegal drugs like cannabis in the last year.I do not have a major illness with a life expectancy of less than one year.I need a procedure to repair the outflow tract from my right ventricle.My heart has a high pressure gradient or severe valve leakage, or both.I am a sexually active female not planning to use birth control for 2 years.I need surgery for a condition that is not related to my heart.I am between 2 and 22 years old.You have a prosthetic heart valve in a different location.I have a long-term inflammatory or autoimmune condition.You have a pacemaker or mechanical heart valve already implanted.You have a severe chest wall deformity that would make it difficult to put in a tube.Your white blood cell count is lower than the normal range for your age and gender. For children 2-12 years old, the normal range is 5.0 ×103 /μL. For males 12 years and older, the normal range is 4.5 ×103 /μL, and for females 12 years and older, the normal range is 4.5 ×103 /μL.
Research Study Groups:
This trial has the following groups:- Group 1: Xeltis Bioabsorbable Pulmonary Valved Conduit
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is the team currently recruiting participants for their experiment?
"As per the details on clinicaltrials.gov, this medical trial is not presently enrolling patients. The study was initially posted on May 8th 2017 and its most recent update occurred in January 5th 2022. Although no recruitment is happening currently, there are 198 additional trials looking for volunteers right now."
Answered by AI
Are there a considerable number of American medical facilities administering this experiment?
"This study is recruiting participants from New york Presbyterian Hospital - Columbia University (Xplore1) in NYC, Children's Hospital of Pittsburgh of UPMC (Xplore1) in Pennsylvania and the Children's Hospital of Los Angeles. Additionally, 7 further medical centres are involved with this trial."
Answered by AI
Are elderly individuals excluded from participating in this clinical experiment?
"According to the entrance criteria, only individuals aged 2-21 are eligible for this research. The registry also hosts 112 studies that involve minors and 111 clinical trials specifically tailored towards those over 65 years old."
Answered by AI
To what participants does this trial offer enrollment?
"This study is in search of 56 individuals between the ages 2 and 21 who have congenital heart defects. To qualify, applicants must require RVOT reconstruction that can accommodate a 16 mm, 18mm, 20mm or 22mm valved conduit; be male or female; evidence peak gradient from Right Ventricular to Pulmonary Artery greater than 35 mm Hg or moderate/severe Pulmonary regurgitation (≥3+), unless Ross procedure applies; provide written informed consent alongside their parent/legal representative if applicable; agree to return for all post-procedure follow up visits as well as comply with clinical investigation plan's required"
Answered by AI
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