Xeltis Bioabsorbable Pulmonary Valved Conduit Pivotal Study (Xplore2)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03022708|
Recruitment Status : Enrolling by invitation
First Posted : January 16, 2017
Last Update Posted : June 23, 2021
|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.
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, 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|