Xeltis Bioabsorbable Pulmonary Valved Conduit Pivotal Study (Xplore2)
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|ClinicalTrials.gov Identifier: NCT03022708|
Recruitment Status : Enrolling by invitation
First Posted : January 16, 2017
Last Update Posted : January 26, 2023
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|Condition or disease||Intervention/treatment||Phase|
|Heart Defect, Congenital||Device: Xeltis Bioabsorbable Pulmonary Valved Conduit||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||56 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||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|
|Actual Study Start Date :||May 8, 2017|
|Estimated Primary Completion Date :||December 2023|
|Estimated Study Completion Date :||December 2026|
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:
Device: Xeltis Bioabsorbable Pulmonary Valved Conduit
Surgical implantation of Xeltis Bioabsorbable Pulmonary Valved Conduit
- Composite rate of events of device related death, re-operation or re-intervention at 12 months follow-up. [ Time Frame: 12 months ]Measured once all 12 month follow up visits have been completed
- Overall rate of device related death due to device failure at 6 months follow up post implantation. [ Time Frame: 6 months ]Measured once all 6 month follow up visits have been completed
- Overall rate of mortality at 60 months follow up post implantation. [ Time Frame: 60 months ]Measured once all 60 months follow up visits have been completed
- Overall rate of subjects who require reoperation or re-intervention due to device failure 12 months. [ Time Frame: 12 months ]Measured once all 12 month follow upvisits have been completed .
- 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 ]Measured by echography at 6 and 12 months follow up.
- 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 ]Measured by echography at 6 and 12 months follow up.
- 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 ]Measured with echocardiography at 6, 36, 48 and 60 months follow up.
- Overall satisfaction of the implanting surgeon of the implantation procedure of the Bio-absorbable pulmonary valve conduit [ Time Frame: Day 0 - Implant ]Measured with a questionnaire given to the implanting surgeon at the time of implantation of the pulmonary valve conduit.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
|Ages Eligible for Study:||2 Years to 21 Years (Child, Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- 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.
- 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
- Male: 13 g /dl
- Female 12 g /dl
- 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.
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03022708
|United States, California|
|Children's Hospital of Los Angeles|
|Los Angeles, California, United States, 90027|
|United States, Colorado|
|Children's Hospital Colorado|
|Aurora, Colorado, United States, 80045|
|United States, Florida|
|Joe DiMaggio Children's Hospital|
|Hollywood, Florida, United States, 33021|
|United States, New York|
|New York Presbyterian Hospital - Columbia University (Xplore1)|
|New York, New York, United States, 10032|
|United States, Ohio|
|Cincinnati Children's Hospital Medical Center|
|Cincinnati, Ohio, United States, 45229|
|United States, Pennsylvania|
|Children's Hospital of Pittsburgh of UPMC (Xplore1)|
|Pittsburgh, Pennsylvania, United States, 15224|
|United States, Texas|
|UTSW- Dallas Children's Hospital|
|Dallas, Texas, United States, 75390-8835|
|Multiprofile Hospital for Active Treatment "National cardiology hospital" EAD, Department of Congenital Heart Defects Surgery|
|Institut Jantung Negara Sdn Bhd|
|Kuala Lumpur, Malaysia|
|University Children's Hospital of Cracow|
|Study Director:||Eliane Schutte||Xeltis Inc|
|Other Study ID Numbers:||
|First Posted:||January 16, 2017 Key Record Dates|
|Last Update Posted:||January 26, 2023|
|Last Verified:||January 2023|
|Individual Participant Data (IPD) Sharing Statement:|
|Plan to Share IPD:||No|
|Studies a U.S. FDA-regulated Drug Product:||No|
|Studies a U.S. FDA-regulated Device Product:||Yes|
|Device Product Not Approved or Cleared by U.S. FDA:||Yes|
Heart Defects, Congenital