- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03022708
Xeltis Bioabsorbable Pulmonary Valved Conduit Pivotal Study (Xplore2)
Prospective, Non-randomized, Pivotal Study to Assess the Safety and Efficacy of the Bioabsorbable Pulmonary Valved Conduit in Subjects Undergoing Right Ventricular Outflow Tract (RVOT) Reconstruction
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Sofia, Bulgaria
- Multiprofile Hospital for Active Treatment "National cardiology hospital" EAD, Department of Congenital Heart Defects Surgery
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Kuala Lumpur, Malaysia
- Institut Jantung Negara Sdn Bhd
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Kraków, Poland
- University Children's Hospital of Cracow
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California
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Los Angeles, California, United States, 90027
- Children's Hospital of Los Angeles
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Colorado
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Aurora, Colorado, United States, 80045
- Children's Hospital Colorado
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Florida
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Hollywood, Florida, United States, 33021
- Joe DiMaggio Children's Hospital
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New York
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New York, New York, United States, 10032
- New York Presbyterian Hospital - Columbia University (Xplore1)
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Ohio
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Cincinnati, Ohio, United States, 45229
- Cincinnati Children's Hospital Medical Center
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Pennsylvania
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Pittsburgh, Pennsylvania, United States, 15224
- Children's Hospital of Pittsburgh of UPMC (Xplore1)
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Texas
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Dallas, Texas, United States, 75390-8835
- UTSW- Dallas Children's Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- Need for or presence of prosthetic heart valve at other position.
- Need for concomitant surgical procedures (non-cardiac).
- Patients with previously implanted pacemaker (including defibrillators), or mechanical valves.
- Active infection or requiring current antibiotic therapy (if temporary illness, subject may be a candidate 4 weeks after discontinuation of antibiotics) or viral infection.
- Active endocarditis.
Leukopenia, defined as White Blood cell Count < than:
- 2-12 years: 5.0 ×103 /μL
- 12 years - Adult:
- Male: 4.5×103 /μL
- Female: 4.5 ×103 /μL
Acute or chronic anemia, defined as Hemoglobin < than:
- 2-12 years 11.5 g /dl
- 12-18:
- Male: 13 g /dl
- Female 12 g /dl
- Adult:
- Male: 13.5 g /dl
- Female: 12 g /dl Patients can be transfused to meet eligibility criteria
Thrombocytopenia, defined as Platelet count < than:
- 150,000/mm3 Patients can be transfused to meet eligibility criteria
- Severe chest wall deformity, which would preclude placement of the PV conduit.
- Pulmonary hypertension (≥ half of systemic systolic pressure)
- Right ventricular outflow tract aneurysm.
- Known hypersensitivity to anticoagulants and antiplatelet drugs and to the device materials. .
- Immunocompromised patient defined as: autoimmune disease, patients receiving immunosuppressant drugs or immune stimulant drugs.
- Subject has chronic inflammatory / autoimmune disease.
- Need for emergency cardiac or vascular surgery or intervention.
- Major or progressive non-cardiac disease (liver failure, renal failure, cancer) that has a life expectancy of less than one year.
- Currently participating, or participated within the last 30 days, in an investigational drug or device study.
- Alcohol or drug abuse as defined by DSM IV-TR criteria for substance abuse - this includes the illicit use of cannabis within the last 12 months.
- Pregnancy.
- Females who are sexually active and are not willing to use adequate contraceptive precautions for the next 2 years
- Subject has medical, social or psychosocial factors that, in the opinion of the Investigator, could impact safety or compliance.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: Xeltis Bioabsorbable Pulmonary Valved Conduit
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:
In addition, the PV conduit can be used for the following indications:
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Surgical implantation of Xeltis Bioabsorbable Pulmonary Valved Conduit
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Composite rate of events of device related death, re-operation or re-intervention at 12 months follow-up.
Time Frame: 12 months
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Measured once all 12 month follow up visits have been completed
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12 months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Overall rate of device related death due to device failure at 6 months follow up post implantation.
Time Frame: 6 months
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Measured once all 6 month follow up visits have been completed
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6 months
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Overall rate of mortality at 60 months follow up post implantation.
Time Frame: 60 months
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Measured once all 60 months follow up visits have been completed
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60 months
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Overall rate of subjects who require reoperation or re-intervention due to device failure 12 months.
Time Frame: 12 months
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Measured once all 12 month follow upvisits have been completed .
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12 months
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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.
Time Frame: 6 and 12 months
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Measured by echography at 6 and 12 months follow up.
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6 and 12 months
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Overall rate of subjects with pulmonary regurgitation of equal or less than moderate at 6 and 12 months follow up.
Time Frame: 6 and 12 months
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Measured by echography at 6 and 12 months follow up.
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6 and 12 months
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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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.
Time Frame: Up to 60 months
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Measured with echocardiography at 6, 36, 48 and 60 months follow up.
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Up to 60 months
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Overall satisfaction of the implanting surgeon of the implantation procedure of the Bio-absorbable pulmonary valve conduit
Time Frame: Day 0 - Implant
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Measured with a questionnaire given to the implanting surgeon at the time of implantation of the pulmonary valve conduit.
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Day 0 - Implant
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Collaborators and Investigators
Sponsor
Investigators
- Study Director: Eliane Schutte, Xeltis Inc
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- XEL-CR-03
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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