Prospective, non-randomized pivotal clinical study to assess the safety and efficacy of the bioabsorbable pulmonary valved conduit in subjects undergoing Right Ventricular Outflow Tract (RVOT) reconstruction
Study ID: STU-2020-1196
This is a multi-center prospective, single-arm, non-randomized, pivotal study that will continue to access the feasibility of the Xeltis Bioabsorbable Pulmonary Valved Conduit in subjects requiring right ventricular outflow tract correction or reconstruction due to congenital heart malformations. initially, 6 patients were enrolled into the study and demonstrated improved device valvular functionality and outcomes when compared to Xplore 1 results. Therefore, it was agreed to amend the early Feasibility Study (eFS) to a pivotal study and enroll 50 additional patients. a maximum of 16 sites will participate in the study. approximately 50% of the study patients will be implanted at uS centers. Competitive enrolment will be applied to the two regions and only if one of the regions has a seriously delay in enrolment ([Greater Than]3-6 months) this 50% balance might shift. a site will be allowed to implant more than 12 patients. This clinical study will commence at the sites with 16 and 18 mm devices. Later on, additional device seizes will be added as enrollment continues. Subjects will provide written informed consent prior to undergoing any study related assessments or procedures, which may occur up to 30 days prior to surgery. after establishing eligibility during screening and confirming continued eligibility at the time of surgery, subjects will undergo surgical implantation of the PV conduit. Subjects will undergo a safety evaluation peri-operatively, at 7 days / discharge, at 6 weeks, at 3 and 6, 9, 12 and 18 months and then subsequently at 24, 36, 48 and 60 months. Subjects where the device could not be implanted for any reason, including the patient receiving the implant but experiencing surgical problems leading to removal of the study device during the initial implantation, will be considered treatment failures and treated with an alternative device of the surgeon's choice. if no implant attempt is made the patient is not considered a treatment failure.
- Cancer Related
- Healthy Volunteers
- UT Southwestern Principal Investigator
- ROBERT DOUGLAS BENJAMIN JAQUISS
objective: To assess the rate of events of death and/or conduit failure requiring re-intervention or reoperation, at 12 months following implantation of the bioabsorbable pulmonary valved conduit. To assess the mortality rate of subjects at 6 months following implantation of the bioabsorbable pulmonary valved conduit. To assess the rate of conduit failure at 6 months, requiring re-intervention or reoperation. To assess the pressure gradient across the pulmonary valve, and regurgitation at 6 and 12 months follow up. Background and Rationale: The bioabsorbable pulmonary valved conduit is used for the reconstruction of the Right Ventricular outflow Tract (RVoT). There is no specific device related surgical procedure necessary for the implantation. Pulmonary valve replacement is the only treatment proven to reduce right ventricular size and improve right ventricular function in the long term.