Treatment Trials

2 Clinical Trials for Various Conditions

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      COMPLETED
      COMMENCE Pulmonary: Clinical Evaluation of Edwards Pericardial Aortic Bioprosthesis (Model 11000A) for Pulmonary Valve Replacement
      Description

      The objective of this trial is to assess the safety and effectiveness of the Edwards Pericardial Aortic Bioprosthesis Model 11000A, in the pulmonary position in pediatric and adult subjects five years or older requiring replacement of their native or prosthetic pulmonary valve.

      Conditions
      Pulmonary Valve InsufficiencyPulmonary Valve DegenerationCongenital Pulmonary Valve Abnormality
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      ACTIVE_NOT_RECRUITING
      COMPASSION XT PAS - Post-approval Study of the SAPIEN XT THV in Patients With Pulmonary Valve Dysfunction
      Description

      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.

      Conditions
      Pulmonary Valve InsufficiencyPulmonary Valve StenosisHeart Defects, CongenitalCongenital AbnormalitiesCardiovascular DiseasesHeart Diseases
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