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Trial record 6 of 605 for:    "Aortic valve stenosis"

TRANscatheter or SurgIcal Aortic Valve ReplacemenT in All-Comers With Severe Aortic Valve Stenosis (TRANSIT)

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ClinicalTrials.gov Identifier: NCT02838199
Recruitment Status : Withdrawn
First Posted : July 20, 2016
Last Update Posted : November 25, 2016
Sponsor:
Collaborator:
CardioVascular Research Foundation, Korea
Information provided by (Responsible Party):
Seung-Jung Park, Asan Medical Center

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.

Condition or disease Intervention/treatment Phase
Aortic Valve Stenosis Device: SAPIEN 3 Procedure: SAVR Phase 4

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Study Start Date : December 2016
Estimated Primary Completion Date : June 2020
Estimated Study Completion Date : December 2030

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: TAVR
Transcatheter aortic valve replacement with SAPIEN 3
Device: SAPIEN 3
Active Comparator: SAVR
Surgical aortic valve replacement
Procedure: SAVR



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

Secondary Outcome Measures :
  1. event rate of cardiovascular mortality [ Time Frame: 30 days or hospital discharge, whichever is longer ]
  2. event rate of cardiovascular mortality [ Time Frame: 31 days to the 1 year ]
  3. event rate of myocardial Infarction [ Time Frame: 30 days or hospital discharge, whichever is longer ]
  4. event rate of myocardial Infarction [ Time Frame: 31 days to the 1 year ]
  5. event rate of all Stroke and transient ischemic attack [ Time Frame: 30 days or hospital discharge, whichever is longer ]
  6. event rate of all Stroke and transient ischemic attack [ Time Frame: 31 days to the 1 year ]
  7. event rate of bleeding [ Time Frame: 30 days or hospital discharge, whichever is longer ]
  8. event rate of bleeding [ Time Frame: 31 days to the 1 year ]
  9. event rate of vascular access site and access-related complication [ Time Frame: 30 days or hospital discharge, whichever is longer ]
  10. event rate of vascular access site and access-related complication [ Time Frame: 31 days to the 1 year ]
  11. event rate of acute kidney injury [ Time Frame: 30 days or hospital discharge, whichever is longer ]
  12. event rate of acute kidney injury [ Time Frame: 31 days to the 1 year ]
  13. event rate of permanent pacemaker insertion [ Time Frame: 30 days or hospital discharge, whichever is longer ]
  14. event rate of permanent pacemaker insertion [ Time Frame: 31 days to the 1 year ]
  15. 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

  16. 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

  17. 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

  18. 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

  19. 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.


  20. 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.


  21. event rate of structural valve deterioration [ Time Frame: 30 days or hospital discharge, whichever is longer ]
  22. event rate of structural valve deterioration [ Time Frame: 31 days to the 1 year ]
  23. NYHA (New York Heart Association Functional Classification) [ Time Frame: 30days and 1 year ]
  24. Valve area [ Time Frame: 30days and 1 year ]
    Aortic valve area (AVA) measured by 2D-transthoracic echocardiography using the continuity equation.

  25. event rate of free from atrial fibrillation [ Time Frame: 30days and 1 year ]


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Ages Eligible for Study:   19 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age must be at least 19 and less than 75 years old
  • Severe aortic valve stenosis with echocardiographically derived criteria: mean gradient > 40mmHg or jet velocity greater than 4.0 m/s AND an initial aortic valve area (AVA) of ≤ 0.8 cm2. Echocardiogram must be within 3 months of the date of the procedure
  • Patient is symptomatic from his/her aortic valve stenosis, as demonstrated by NYHA class II or greater.
  • The patient or guardian agrees to the study protocol and the schedule of clinical and angiographic follow-up, and provides informed, written consent, as approved by the appropriate Institutional Review Board/Ethical Committee of the respective clinical site.

Exclusion Criteria:

  • Life expectancy <1 year due to medical illness
  • Suspected Malignancy
  • Inoperability evaluated by surgeon
  • Concomitant severe coronary artery disease not amenable for percutaneous coronary intervention
  • Concomitant severe mitral valve or significant aorta disease requiring surgery
  • Active bacterial endocarditis within 6 months of procedure
  • Leukopenia (WBC<3000 cell/mL), acute anemia (Hgb<8g/dL), thrombocytopenia (platelet < 50000 cell/mL)
  • Intracardiac thrombus
  • A known contraindication or hypersensitivity to all anticoagulation regimens, or inability to be anticoagulated for the study procedure.
  • Native aortic annulus size < 18 mm or > 25 mm as measured by echocardiogram.
  • Expectation that patient will not improve despite treatment of aortic stenosis
  • Patients who are actively participating in another drug or device investigational study, which have not completed the primary endpoint follow-up period.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02838199


Locations
Korea, Republic of
Asan Medical Center
Seoul, Songpa-gu, Korea, Republic of, 138-736
Sponsors and Collaborators
Seung-Jung Park
CardioVascular Research Foundation, Korea
Investigators
Principal Investigator: Suck-jung Choo, MD Asan Medical Center

Responsible Party: Seung-Jung Park, professor of medicine, Asan Medical Center
ClinicalTrials.gov Identifier: NCT02838199     History of Changes
Other Study ID Numbers: AMCCV2016-16
First Posted: July 20, 2016    Key Record Dates
Last Update Posted: November 25, 2016
Last Verified: November 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by Seung-Jung Park, Asan Medical Center:
Transcatheter aortic valve replacement
TAVR
TAVI
SAVR

Additional relevant MeSH terms:
Constriction, Pathologic
Aortic Valve Stenosis
Pathological Conditions, Anatomical
Heart Valve Diseases
Heart Diseases
Cardiovascular Diseases
Ventricular Outflow Obstruction