Treatment Trials

3 Clinical Trials for Various Conditions

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      ACTIVE_NOT_RECRUITING
      COMPASSION S3 Post-Approval Study
      Description

      This study will monitor device performance and outcomes of the SAPIEN 3 Transcatheter Heart Valve (THV) System in subjects with a dysfunctional right ventricular outflow tract (RVOT) conduit or previously implanted surgical valve in the pulmonic position with a clinical indication for intervention.

      Conditions
      Complex Congenital Heart DefectDysfunctional RVOT ConduitPulmonary Valve InsufficiencyPulmonary Valve DegenerationPulmonary Valve; Obstruction
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      COMPLETED
      COMPASSION - COngenital Multicenter Trial of Pulmonic VAlve Regurgitation Studying the SAPIEN InterventIONal THV
      Description

      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.

      Conditions
      Pulmonary Valve InsufficiencyPulmonary RegurgitationDysfunctional RVOT ConduitPulmonary ObstructionPulmonary Stenosis
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      COMPLETED
      Suture Closure AFtEr VEIN Access for Cardiac Procedures (SAFE-VEIN) Trial
      Description

      Primary objective: To compare the safety and efficacy of closure strategies post venous access procedures. Hypothesis: We anticipate that the use of a venous closure device will decrease the time to hemostasis (TTH), time to ambulation (TTA) and time to discharge (TTD) compared to conventional methods of closure following venous access procedure.

      Conditions
      Atrial FibrillationAtrial FlutterHeart BlockPulmonary Embolism and ThrombosisMitral Valve RepairSinus Node DysfunctionBradycardiaBrady-tachy Syndrome
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