Clinical Trial: Surgical Implantation of TRAnscatheter vaLve in Native Mitral Annular Calcification (SITRAL) Study

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: Surgical Implantation of TRAnscatheter vaLve in Native Mitral Annular Calcification (SITRAL) Study

Brief Summary: The purpose of this study is to establish the safety and feasibility of the Edwards SAPIEN 3 valve in subjects with mitral annular calcification (MAC) associated with mitral stenosis (MS) and/or mitral regurgitation who are at high-risk for mitral valve surgery or deemed inoperable due to the extent of calcification.

Detailed Summary:

Technical Success:

Alive, with

  • Successful access, delivery and retrieval of the device delivery system, and
  • Deployment and correct positioning (including repositioning/recapture if needed) of the single intended device, and
  • No need for additional unplanned or emergency surgery or re-intervention related to the device or access procedure

Device Success:

Alive and stroke free, with

  • Original intended device in place, and
  • No additional surgical or interventional procedures related to access or the device since completion of the original procedure (i.e., exit from the cath lab/Operating Room(OR)), and

  • Intended performance of the device:

    • Structural performance: No migration, embolization, detachment, fracture, hemolysis, thrombosis (including reduced leaflet motion) or endocarditis, etc, and
    • Hemodynamic performance: Maintenance of relief of stenosis or insufficiency without producing the opposite (Stenosis = Mitral Valve Area (MVA) < 1.5cm2 and Mitral Valve (MV) gradient > 5mmHg, Insufficiency = Mitral Regurgitation (MR) >1+), and
    • Absence of para-device complications (e.g., Paravalvular Leak (PVL) > mild, need for a Permanent Pacemaker (PPM), erosion, Annular rupture or Aortic Valve (AV) Groove disruption, Left Ventricular Outflow Tract (LVOT) gradient increase > 1
      Sponsor: Baylor Research Institute

      Current Primary Outcome:

      • Procedural success [ Time Frame: 30 days ]

        Procedural Success is defined as:

        1. Device success, and
        2. No device or procedure related serious adverse events (SAEs) (Life threatening bleed; major vascular or cardiac structural complications requiring unplanned reintervention or surgery; stage 2 or 3 acute kidney injury (AKI) (includes new dialysis); myocardial infarction (MI) or need for percutaneous coronary intervention (PCI)/coronary artery bypass graft (CABG); severe heart failure (HF) or hypotension requiring intravenous (IV) inotrope, ultrafiltration or mechanical circulatory support; prolonged intubation ( > 48 hours)
      • Technical success [ Time Frame: Procedure Stop Time ]

        Technical Success is defined as:

        1. Alive, with
        2. Successful access, delivery and retrieval of the device delivery system, and
        3. Deployment and correct positioning (including repositioning/recapture if needed) of the single intended device, and
        4. No need for additional unplanned or emergency surgery or re-intervention related to the device or access procedure
      • Device success [ Time Frame: 30 days ]

        Device Success is defined as:

        1. Ali

          Original Primary Outcome: Same as current

          Current Secondary Outcome:

          • Device success [ Time Frame: 6 months ]

            Device Success is defined as:

            1. Alive and stroke free, with
            2. Original intended device in place, and
            3. No additional surgical or interventional procedures related to access or the device since completion of the original procedure (i.e., exit from the cath lab/operating room (OR)), and

            4. Intended performance of the device:

              1. Structural performance: No migration, embolization, detachment, fracture, hemolysis, thrombosis (including reduced leaflet motion) or endocarditis, etc, and
              2. Hemodynamic performance: Maintenance of relief of stenosis or insufficiency without producing the opposite (Stenosis = MVA < 1.5cm2 and MV gradient > 5mmHg, Insufficiency = MR >1+), and
              3. Absence of para-device complications (e.g., PVL > mild, need for a PPM, erosion, Annular rupture or AV Groove disruption, LVOT gradient increase > 10mmHg)
          • Device Success [ Time Frame: 1 year ]

            Device Success is defined as:

            1. Alive and stroke free, with
            2. Original intended device in place, and
            3. No additional surgical or interventional procedures related to access or the device since completion of the original procedure (i.e., exit from the cath lab/OR), and

            4. Intended performance of the device:

              1. Structural performance: No migration, embolization, detachment, fracture, hemolysis, thrombosis (including reduced leaflet motion) or endocarditis, etc, and
              2. Hemodynamic performance: Maintenance of relief of stenosis or insufficiency without producing the opposite (Stenosis = MVA < 1.5cm2 and MV gradient > 5mmHg, Insufficiency = MR >1+), and
              3. Absence of para-device complications (e.g., PVL > mild, need for a PPM, erosion, Annular rupture or AV Groove disruption, LVOT gradient increase > 10mmHg)
          • Subject success [ Time Frame: 1 year ]

            Subject Success is defined as:

            All of the following must be present:

            I. Device success (either optimal or acceptable), and II. Patient returned to the pre-procedural setting: and III. No rehospitalizations or reinterventions for the underlying condition (e.g., mitral regurgitation, heart failure); and IV. Improvement from baseline in symptoms (e.g., NYHA improvement by > or = 1 functional class); and V. Improvement from baseline in functional status (e.g., 6-min walk test improvement by > or = 50 m); and VI. Improvement from baseline in quality-of-life (e.g., Kansas City Cardiomyopathy Questionnaire improvement by > or = 10)



          Original Secondary Outcome: Same as current

          Information By: Baylor Research Institute

          Dates:
          Date Received: May 4, 2016
          Date Started: April 2016
          Date Completion: December 2018
          Last Updated: November 15, 2016
          Last Verified: November 2016