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

Aortic Valve Stenosis Clinical Trial

— 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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02838199
• Other study ID #: AMCCV2016-16
• Status: Withdrawn
• Phase: Phase 4
• First received: July 6, 2016
• Last updated: November 22, 2016
• Start date: December 2016
• Est. completion date: December 2030

Study information

• Verified date: November 2016
• Source: Asan Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 2030
• Est. primary completion date: June 2020
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 19 Years to 75 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Aortic Valve Stenosis
• Constriction, Pathologic

Intervention

Device:
• SAPIEN 3

Procedure:
• SAVR

Locations

Country	Name	City	State
Korea, Republic of	Asan Medical Center	Seoul	Songpa-gu

Sponsors (2)

Lead Sponsor	Collaborator
Seung-Jung Park	CardioVascular Research Foundation, Korea

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	event rate of all-cause mortality		1 year	Yes
Secondary	event rate of cardiovascular mortality		30 days or hospital discharge, whichever is longer	Yes
Secondary	event rate of cardiovascular mortality		31 days to the 1 year	Yes
Secondary	event rate of myocardial Infarction		30 days or hospital discharge, whichever is longer	Yes
Secondary	event rate of myocardial Infarction		31 days to the 1 year	Yes
Secondary	event rate of all Stroke and transient ischemic attack		30 days or hospital discharge, whichever is longer	Yes
Secondary	event rate of all Stroke and transient ischemic attack		31 days to the 1 year	Yes
Secondary	event rate of bleeding		30 days or hospital discharge, whichever is longer	Yes
Secondary	event rate of bleeding		31 days to the 1 year	Yes
Secondary	event rate of vascular access site and access-related complication		30 days or hospital discharge, whichever is longer	Yes
Secondary	event rate of vascular access site and access-related complication		31 days to the 1 year	Yes
Secondary	event rate of acute kidney injury		30 days or hospital discharge, whichever is longer	Yes
Secondary	event rate of acute kidney injury		31 days to the 1 year	Yes
Secondary	event rate of permanent pacemaker insertion		30 days or hospital discharge, whichever is longer	Yes
Secondary	event rate of permanent pacemaker insertion		31 days to the 1 year	Yes
Secondary	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	Yes
Secondary	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	Yes
Secondary	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	No
Secondary	event rate of prosthetic valve dysfunction	Prosthetic aortic valve stenosis Prosthesis-patient mismatch Prosthetic aortic valve regurgitation	31 days to the 1 year	No
Secondary	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	Yes
Secondary	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	Yes
Secondary	event rate of structural valve deterioration		30 days or hospital discharge, whichever is longer	No
Secondary	event rate of structural valve deterioration		31 days to the 1 year	No
Secondary	NYHA (New York Heart Association Functional Classification)		30days and 1 year	No
Secondary	Valve area	Aortic valve area (AVA) measured by 2D-transthoracic echocardiography using the continuity equation.	30days and 1 year	No
Secondary	event rate of free from atrial fibrillation		30days and 1 year	No