Clinical Trial: Multicenter Trial of Congenital Pulmonic Valve Dysfunction Studying the SAPIEN 3 THV With the Alterra Adaptive Prestent

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

Official Title: Multicenter Early Feasibility Study of Congenital Pulmonic Valve Dysfunction Studying the SAPIEN 3 Transcather Heart Valve With the Alterra Adaptive Prestent

Brief Summary: To demonstrate the safety and functionality of the Edwards Alterra Adaptive Prestent in conjunction with the Edwards SAPIEN 3 Transcatheter Heart Valve (THV) System in patients with a dysfunctional right ventricular outflow tract/pulmonary valve (RVOT/PV) who are indicated for treatment of pulmonary regurgitation (PR).

Detailed Summary:
Sponsor: Edwards Lifesciences

Current Primary Outcome: Device Success [ Time Frame: 30 days ]

Defined as a non-hierarchical composite of:

  • Single Alterra Adaptive Prestent deployed into the desired location
  • Single THV implanted in the desired location within the Alterra Adaptive Prestent (staged procedures allowed)
  • Right ventricle to pulmonary artery (RV-PA) peak-to-peak gradient < 35 mmHg post-THV implantation
  • Less than moderate total PR by discharge TTE (or earliest evaluable TTE)
  • Free of Alterra explant at 24 hours post-implantation


Original Primary Outcome: Same as current

Current Secondary Outcome: Free from THV dysfunction [ Time Frame: 6 months ]

THV dysfunction is defined as a non-hierarchical composite of RVOT/PV reintervention

  • Moderate or greater total PR via Transthoracic Echocardiography (TTE)
  • Mean RVOT/PV gradient ≥35 mmHg via TTE


Original Secondary Outcome: Same as current

Information By: Edwards Lifesciences

Dates:
Date Received: April 24, 2017
Date Started: July 2017
Date Completion: December 2022
Last Updated: May 16, 2017
Last Verified: May 2017