Clinical Trial: Xeltis Bioabsorbable Pulmonary Valved Conduit Early Feasibility Study

Study Status: Not yet recruiting
Recruit Status: Not yet recruiting
Study Type: Interventional

Official Title: Prospective, Non-randomized, Open Label Clinical Study to Assess the Feasibility of the Bioabsorbable Pulmonary Valved Conduit in Subjects Undergoing Right Ventricular Outflow Tract (RVOT) Reconstruct

Brief Summary: This is a multi-center prospective, single-arm, non-randomized, open label study to assess feasibility of the Xeltis Bioabsorbable Pulmonary Valved Conduit in subjects requiring Right Ventricular Outflow Tract correction or reconstruction due to congenital heart malformations.

Detailed Summary:
Sponsor: Xeltis

Current Primary Outcome:

• Freedom of device related death due to device failure at 6 months follow up post implantation [ Time Frame: 6 months ]
  Measured by the fact that the patient is still alive at the time of the 6 month FU visit
• Freedom of device related death at 12 months follow-up [ Time Frame: 12 months ]
  Measured by the fact that the patient is still alive at the time of the 12 month FU visit
• Freedom of re-operation or re-intervention at 6 months follow-up due to device failure [ Time Frame: 6 months ]
  Measured by the fact that the patient did not have a reoperation or reintervention during the first 6 months

Original Primary Outcome:

• Freedom of device related death due to device failure at 6 months follow up post implantation, measured by the fact that the patient is still alive at the time of the 6 month FU visit [ Time Frame: 6 months ]
• Freedom of device related death at 12 months follow-up, measured by the fact that the patient is still alive at the time of the 12 month FU visit [ Time Frame: 12 months ]
• Freedom of re-operation or re-intervention at 6 months follow-up due to device failure, measured by the fact that the patient did not have a reoperation or reintervention during the first 6 months [ Time Frame: 6 months ]

Current Secondary Outcome:

• Overall rate of mortality at 60 months follow up post implantation [ Time Frame: 60 months ]
  Measured by the fact that the patient is still alive at the time of the 60 month FU visit
• Overall rate of subjects who require reoperation or reintervention due to device failure at 12 months [ Time Frame: 12 months ]
  Measured by the fact that the patient did not have a reoperation or reintervention during the first 12 months
• Overall rate of subjects with a mean pressure gradient across the area of conduit implantation (RV to PA) of less than 40 mm Hg at 6 and 12 months follow up [ Time Frame: 6 and 12 months ]
  Measured with echocardiography 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 with echocardiography at 6 and 12 months follow up.

Original Secondary Outcome:

• Overall rate of mortality at 60 months follow up post implantation, measured by the fact that the patient is still alive at the time of the 60 month FU visit [ Time Frame: 60 months ]
• Overall rate of subjects who require reoperation or reintervention due to device failure at 12 months, measured by the fact that the patient did not have a reoperation or reintervention during the first 12 months [ Time Frame: 12 months ]
• Overall rate of subjects with a mean pressure gradient across the area of conduit implantation (RV to PA) of less than 40 mm Hg at 6 and 12 months follow up, measured with echocardiography at 6 and 12 months follow up. [ Time Frame: 6 and 12 months ]
• Overall rate of subjects with pulmonary regurgitation of equal or less than moderate at 6 and 12 months follow up, measured with echocardiography at 6 and 12 months follow up. [ Time Frame: 6 and 12 months ]

Information By: Xeltis

Dates:
Date Received: January 10, 2017
Date Started: May 2017
Date Completion: December 2022
Last Updated: May 5, 2017
Last Verified: May 2017