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

Primary Purpose

Aortic Valve Stenosis

Status
Withdrawn
Phase
Phase 4
Locations
Korea, Republic of
Study Type
Interventional
Intervention
SAPIEN 3
SAVR
Sponsored by
Seung-Jung Park
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Aortic Valve Stenosis focused on measuring Transcatheter aortic valve replacement, TAVR, TAVI, SAVR

Eligibility Criteria

19 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Asan Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

TAVR

SAVR

Arm Description

Transcatheter aortic valve replacement with SAPIEN 3

Surgical aortic valve replacement

Outcomes

Primary Outcome Measures

event rate of all-cause mortality

Secondary Outcome Measures

event rate of cardiovascular mortality
event rate of cardiovascular mortality
event rate of myocardial Infarction
event rate of myocardial Infarction
event rate of all Stroke and transient ischemic attack
event rate of all Stroke and transient ischemic attack
event rate of bleeding
event rate of bleeding
event rate of vascular access site and access-related complication
event rate of vascular access site and access-related complication
event rate of acute kidney injury
event rate of acute kidney injury
event rate of permanent pacemaker insertion
event rate of permanent pacemaker insertion
event rate of other TAVR-related complication
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
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
Prosthetic aortic valve stenosis Prosthesis-patient mismatch Prosthetic aortic valve regurgitation
event rate of prosthetic valve dysfunction
Prosthetic aortic valve stenosis Prosthesis-patient mismatch Prosthetic aortic valve regurgitation
event rate of composite event for device success, early safety, clinical efficacy
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
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
event rate of structural valve deterioration
NYHA (New York Heart Association Functional Classification)
Valve area
Aortic valve area (AVA) measured by 2D-transthoracic echocardiography using the continuity equation.
event rate of free from atrial fibrillation

Full Information

First Posted
July 6, 2016
Last Updated
November 22, 2016
Sponsor
Seung-Jung Park
Collaborators
CardioVascular Research Foundation, Korea
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1. Study Identification

Unique Protocol Identification Number
NCT02838199
Brief Title
TRANscatheter or SurgIcal Aortic Valve ReplacemenT in All-Comers With Severe Aortic Valve Stenosis
Acronym
TRANSIT
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 Type
Interventional

2. Study Status

Record Verification Date
November 2016
Overall Recruitment Status
Withdrawn
Study Start Date
December 2016 (undefined)
Primary Completion Date
June 2020 (Anticipated)
Study Completion Date
December 2030 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Seung-Jung Park
Collaborators
CardioVascular Research Foundation, Korea

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Aortic Valve Stenosis
Keywords
Transcatheter aortic valve replacement, TAVR, TAVI, SAVR

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
TAVR
Arm Type
Experimental
Arm Description
Transcatheter aortic valve replacement with SAPIEN 3
Arm Title
SAVR
Arm Type
Active Comparator
Arm Description
Surgical aortic valve replacement
Intervention Type
Device
Intervention Name(s)
SAPIEN 3
Intervention Type
Procedure
Intervention Name(s)
SAVR
Primary Outcome Measure Information:
Title
event rate of all-cause mortality
Time Frame
1 year
Secondary Outcome Measure Information:
Title
event rate of cardiovascular mortality
Time Frame
30 days or hospital discharge, whichever is longer
Title
event rate of cardiovascular mortality
Time Frame
31 days to the 1 year
Title
event rate of myocardial Infarction
Time Frame
30 days or hospital discharge, whichever is longer
Title
event rate of myocardial Infarction
Time Frame
31 days to the 1 year
Title
event rate of all Stroke and transient ischemic attack
Time Frame
30 days or hospital discharge, whichever is longer
Title
event rate of all Stroke and transient ischemic attack
Time Frame
31 days to the 1 year
Title
event rate of bleeding
Time Frame
30 days or hospital discharge, whichever is longer
Title
event rate of bleeding
Time Frame
31 days to the 1 year
Title
event rate of vascular access site and access-related complication
Time Frame
30 days or hospital discharge, whichever is longer
Title
event rate of vascular access site and access-related complication
Time Frame
31 days to the 1 year
Title
event rate of acute kidney injury
Time Frame
30 days or hospital discharge, whichever is longer
Title
event rate of acute kidney injury
Time Frame
31 days to the 1 year
Title
event rate of permanent pacemaker insertion
Time Frame
30 days or hospital discharge, whichever is longer
Title
event rate of permanent pacemaker insertion
Time Frame
31 days to the 1 year
Title
event rate of other TAVR-related complication
Description
Conversion to open surgery Coronary obstruction Mitral valve apparatus damage or dysfunction Cardiac tamponade Endocarditis Valve thrombosis Valve malpositioning TAV-in-TAV deployment
Time Frame
30 days or hospital discharge, whichever is longer
Title
event rate of other TAVR-related complication
Description
Conversion to open surgery Coronary obstruction Mitral valve apparatus damage or dysfunction Cardiac tamponade Endocarditis Valve thrombosis Valve malpositioning TAV-in-TAV deployment
Time Frame
31 days to the 1 year
Title
event rate of prosthetic valve dysfunction
Description
Prosthetic aortic valve stenosis Prosthesis-patient mismatch Prosthetic aortic valve regurgitation
Time Frame
30 days or hospital discharge, whichever is longer
Title
event rate of prosthetic valve dysfunction
Description
Prosthetic aortic valve stenosis Prosthesis-patient mismatch Prosthetic aortic valve regurgitation
Time Frame
31 days to the 1 year
Title
event rate of composite event for device success, early safety, clinical efficacy
Description
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.
Time Frame
30 days or hospital discharge, whichever is longer
Title
event rate of composite event for device success, early safety, clinical efficacy
Description
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.
Time Frame
31 days to the 1 year
Title
event rate of structural valve deterioration
Time Frame
30 days or hospital discharge, whichever is longer
Title
event rate of structural valve deterioration
Time Frame
31 days to the 1 year
Title
NYHA (New York Heart Association Functional Classification)
Time Frame
30days and 1 year
Title
Valve area
Description
Aortic valve area (AVA) measured by 2D-transthoracic echocardiography using the continuity equation.
Time Frame
30days and 1 year
Title
event rate of free from atrial fibrillation
Time Frame
30days and 1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Suck-jung Choo, MD
Organizational Affiliation
Asan Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Asan Medical Center
City
Seoul
State/Province
Songpa-gu
ZIP/Postal Code
138-736
Country
Korea, Republic of

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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

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