Clinical Trial: COMPASSION - COngenital Multicenter Trial of Pulmonic VAlve Regurgitation Studying the SAPIEN InterventIONal THV

Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Interventional

Official Title: Implantation of the SAPIEN Transcatheter Heart Valve (THV) in the Pulmonic Position

Brief Summary: To assess the safety and effectiveness of pulmonic THV implantation in subjects with dysfunctional RVOT conduit requiring treatment for moderate or severe pulmonary regurgitation (≥3+ pulmonary regurgitation) and/or RVOT conduit obstruction (mean gradient of >=35mmHg) by TTE.

Detailed Summary: The study design is a multi-center, prospective, non-randomized study of up to 70 implanted subjects (US) with no site representing more than 30% of the implanted subjects. The subjects will include those subjects who have previously undergone placement of a conduit between the right ventricle and pulmonary artery and now present with a dysfunctional RVOT conduit requiring treatment for moderate or severe pulmonary regurgitation and/or RVOT conduit obstruction.
Sponsor: Edwards Lifesciences

Current Primary Outcome: Freedom From Device or Procedure Related Death or Reintervention [ Time Frame: 1 year ]

Original Primary Outcome: Freedom from death and reoperation at 6 months. [ Time Frame: 6 Months ]

Current Secondary Outcome:

  • Freedom From MACCE [ Time Frame: 6 Months ]
    Clinical Events Committee (CEC) adjudicated.
  • Functional Improvement [ Time Frame: 6 months ]

    Functional improvement at 6 months as defined by:

    a) Improved valve hemodynamics as demonstrated via Transthoracic Echo: i) Decrease in pulmonary regurgitation to mild or less for regurgitant lesions ii) Decrease in mean pulmonary gradient to less than 30 mmHg for stenotic lesions iii) Improvement in both i) and ii) above for mixed lesions b) Improvement of ≥ 1 NYHA functional class from baseline for patients with NYHA functional class ≥ 2 at baseline c) Freedom from recurrent pulmonary stenosis.



Original Secondary Outcome:

  • Freedom from MACCE at 6 months [ Time Frame: 6 Months ]
  • Functional Improvement [ Time Frame: 6 months ]


Information By: Edwards Lifesciences

Dates:
Date Received: May 9, 2008
Date Started: April 2008
Date Completion: November 2019
Last Updated: February 6, 2017
Last Verified: February 2017