Clinical Trial: COMPASSION XT PAS - Post-approval Study of the SAPIEN XT THV in Patients With Pulmonary Valve Dysfunction

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

Official Title: New Enrollment SAPIEN XT Post-Approval Study

Brief Summary: This study will confirm the safety and effectiveness of the Edwards Lifesciences SAPIEN XT Transcatheter Heart Valve (THV) System in patients with a dysfunctional right ventricular outflow tract (RVOT) conduit with a clinical indication for intervention in a post-market setting.

Detailed Summary: The study is a prospective, non-randomized, multi-center clinical study to assess the safety and effectiveness of pulmonic implantation of the SAPIEN THV in patients with dysfunctional RVOT conduits requiring treatment for moderate or severe pulmonary regurgitation (PR) by transthoracic echocardiography (TTE) and/or RVOT conduit obstruction with a mean gradient of ≥ 35 mmHg by TTE.
Sponsor: Edwards Lifesciences

Current Primary Outcome: Freedom from device- or procedure-related death or reintervention [ Time Frame: 1 year ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

• Decrease in pulmonary regurgitation to mild or less for regurgitant lesions [ Time Frame: 1 year ]
  Assessed via transthoracic echocardiogram (TTE)
• Decrease in RVOT mean gradient to less than 30 mmHg for stenotic lesions [ Time Frame: 1 year ]
  Assessed via TTE
• Device Success [ Time Frame: 48 Hours Prior to Discharge ]

  Device Success is a composite of:

  • Deployment of the valve to the target area, and
  • Removal of the delivery catheter out of the body, and
  • Improvement in pulmonary regurgitation to mild or less per the earliest evaluable TTE.

Original Secondary Outcome: Same as current

Information By: Edwards Lifesciences

Dates:
Date Received: October 19, 2016
Date Started: May 2017
Date Completion: January 2024
Last Updated: April 27, 2017
Last Verified: April 2017