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

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

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.

Study Overview

• Status: Withdrawn
• Conditions: Aortic Valve Stenosis
• Intervention / Treatment: Device: SAPIEN 3; Procedure: SAVR

• Study Type: Interventional
• Phase: Phase 4

Contacts and Locations

Study Locations

• Korea, Republic of
  • Songpa-gu
    • Seoul, Songpa-gu, Korea, Republic of, 138-736
      • Asan Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years to 75 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: TAVR; Transcatheter aortic valve replacement with SAPIEN 3	Device: SAPIEN 3
ACTIVE_COMPARATOR: SAVR; Surgical aortic valve replacement	Procedure: SAVR

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
event rate of all-cause mortality	1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
event rate of cardiovascular mortality		30 days or hospital discharge, whichever is longer
event rate of cardiovascular mortality		31 days to the 1 year
event rate of myocardial Infarction		30 days or hospital discharge, whichever is longer
event rate of myocardial Infarction		31 days to the 1 year
event rate of all Stroke and transient ischemic attack		30 days or hospital discharge, whichever is longer
event rate of all Stroke and transient ischemic attack		31 days to the 1 year
event rate of bleeding		30 days or hospital discharge, whichever is longer
event rate of bleeding		31 days to the 1 year
event rate of vascular access site and access-related complication		30 days or hospital discharge, whichever is longer
event rate of vascular access site and access-related complication		31 days to the 1 year
event rate of acute kidney injury		30 days or hospital discharge, whichever is longer
event rate of acute kidney injury		31 days to the 1 year
event rate of permanent pacemaker insertion		30 days or hospital discharge, whichever is longer
event rate of permanent pacemaker insertion		31 days to the 1 year
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	30 days or hospital discharge, whichever is longer
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	31 days to the 1 year
event rate of prosthetic valve dysfunction	Prosthetic aortic valve stenosis Prosthesis-patient mismatch Prosthetic aortic valve regurgitation	30 days or hospital discharge, whichever is longer
event rate of prosthetic valve dysfunction	Prosthetic aortic valve stenosis Prosthesis-patient mismatch Prosthetic aortic valve regurgitation	31 days to the 1 year
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.	30 days or hospital discharge, whichever is longer
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.	31 days to the 1 year
event rate of structural valve deterioration		30 days or hospital discharge, whichever is longer
event rate of structural valve deterioration		31 days to the 1 year
NYHA (New York Heart Association Functional Classification)		30days and 1 year
Valve area	Aortic valve area (AVA) measured by 2D-transthoracic echocardiography using the continuity equation.	30days and 1 year
event rate of free from atrial fibrillation		30days and 1 year

Collaborators and Investigators

• Sponsor: Seung-Jung Park
• Collaborators: CardioVascular Research Foundation, Korea
• Investigators: Principal Investigator: Suck-jung Choo, MD, Asan Medical Center

Study record dates

Study Major Dates

• Study Start: December 1, 2016
• Primary Completion (ANTICIPATED): June 1, 2020
• Study Completion (ANTICIPATED): December 1, 2030

Study Registration Dates

• First Submitted: July 6, 2016
• First Submitted That Met QC Criteria: July 17, 2016
• First Posted (ESTIMATE): July 20, 2016

Study Record Updates

• Last Update Posted (ESTIMATE): November 25, 2016
• Last Update Submitted That Met QC Criteria: November 22, 2016
• Last Verified: November 1, 2016

More Information

Terms related to this study

• Keywords: TAVI; TAVR; Transcatheter aortic valve replacement; SAVR
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Pathological Conditions, Anatomical; Aortic Valve Disease; Heart Valve Diseases; Ventricular Outflow Obstruction; Aortic Valve Stenosis; Constriction, Pathologic
• Other Study ID Numbers: AMCCV2016-16

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED