Clinical Trial: TRANscatheter or SurgIcal Aortic Valve ReplacemenT in All-Comers With Severe Aortic Valve Stenosis

Study Status: Withdrawn
Recruit Status: Withdrawn
Study Type: Interventional

Official Title: Prospective, Open Label, Multicenter, Dual Arm, Randomized Trial of TRANscatheter or SurgIcal Aortic Valve ReplacemenT in All-Comers With Severe Aortic Valve Stenosis

Brief Summary: The purpose of this study is to determine that Transcatheter aortic valve replacement (TAVR) with SAPIEN 3 is superior to traditional surgical aortic valve replacement(SAVR) with bio-prosthesis regarding the rate of all-cause mortality at 1 year in patients with symptomatic severe aortic valve stenosis.

Detailed Summary:
Sponsor: Seung-Jung Park

Current Primary Outcome: event rate of all-cause mortality [ Time Frame: 1 year ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

• event rate of cardiovascular mortality [ Time Frame: 30 days or hospital discharge, whichever is longer ]
• event rate of cardiovascular mortality [ Time Frame: 31 days to the 1 year ]
• event rate of myocardial Infarction [ Time Frame: 30 days or hospital discharge, whichever is longer ]
• event rate of myocardial Infarction [ Time Frame: 31 days to the 1 year ]
• event rate of all Stroke and transient ischemic attack [ Time Frame: 30 days or hospital discharge, whichever is longer ]
• event rate of all Stroke and transient ischemic attack [ Time Frame: 31 days to the 1 year ]
• event rate of bleeding [ Time Frame: 30 days or hospital discharge, whichever is longer ]
• event rate of bleeding [ Time Frame: 31 days to the 1 year ]
• event rate of vascular access site and access-related complication [ Time Frame: 30 days or hospital discharge, whichever is longer ]
• event rate of vascular access site and access-related complication [ Time Frame: 31 days to the 1 year ]
• event rate of acute kidney injury [ Time Frame: 30 days or hospital discharge, whichever is longer ]
• event rate of acute kidney injury [ Time Frame: 31 days to the 1 year ]
• event rate of permanent pacemaker insertion [ Time Frame: 30 days or hospital discharge, whichever is longer ]
• event rate of permanent pacemaker insertion [ Time Frame: 31 days to the 1 year ]
• event rate of other TAVR-related complication [ Time Frame: 30 days or hospital discharge, whichever is longer ]
  Conversion to open surgery Coronary obstruction Mitral valve apparatus damage or dysfunction Cardiac tamponade Endocarditis Valve thrombosis Valve malpositioning TAV-in-TAV deployment
• event rate of other TAVR-related complication [ Time Frame: 31 days to the 1 year ]
  Conversion to open surgery Coronary obstruction Mitral valve apparatus damage or dysfunction Cardiac tamponade Endocarditis Valve thrombosis Valve malpositioning TAV-in-TAV deployment
• event rate of prosthetic valve dysfunction [ Time Frame: 30 days or hospital discharge, whichever is longer ]
  Prosthetic aortic valve stenosis Prosthesis-patient mismatch Prosthetic aortic valve regurgitation
• event rate of prosthetic valve dysfunction [ Time Frame: 31 days to the 1 year ]
  Prosthetic aortic valve stenosis Prosthesis-patient mismatch Prosthetic aortic valve regurgitation
• event rate of composite event for device success, early safety, clinical efficacy [ Time Frame: 30 days or hospital discharge, whichever is longer ]

  Number of cases with following events ;

  A. Device success

  or

  B. Early safety (At 30 days):

  All-cause mortality, all stroke, life threatening bleeding, acute kidney injury, coronary obstruction requiring intervention, major vascular complication, valve-related dysfunction requiring repeat procedure.

  or

  C. Clinical efficacy (After 30 days):

  All-cause mortality, all stroke, requiring hospitalization for valve-related symptoms or worsening congestive heart failure, NYHA class III or IV, valve related dysfunction.

• event rate of composite event for device success, early safety, clinical efficacy [ Time Frame: 31 days to the 1 year ]

  Number of cases with following events ;

  A. Device success

  or

  B. Early safety (At 30 days):

  All-cause mortality, all stroke, life threatening bleeding, acute kidney injury, coronary obstruction requiring intervention, major vascular complication, valve-related dysfunction requiring repeat procedure.

  or

  C. Clinical efficacy (After 30 days):

  All-cause mortality, all stroke, requiring hospitalization for valve-related symptoms or worsening congestive heart failure, NYHA class III or IV, valve related dysfunction.

• event rate of structural valve deterioration [ Time Frame: 30 days or hospital discharge, whichever is longer ]
• Same as current
  
  Information By: Asan Medical Center
  

  Dates:
  Date Received: July 6, 2016
  Date Started: December 2016
  Date Completion: December 2030
  Last Updated: November 22, 2016
  Last Verified: November 2016