To establish the safety and effectiveness of surgical aortic valve replacement (SAVR) in patients with isolated severe, calcific aortic stenosis who are at low surgical risk.
This study is the Prospective, Randomized, Controlled, Multi-center Study of Isolated SAVR in Low Risk AS Patients (The AMETHYST trial). Patients will be randomized 1:1 to receive either SAVR or transcatheter heart valve replacement (TAVR) with a commercially available surgical and transcatheter bioprosthetic valves. The aim of this study was to assess the non-inferiority of SAVR compared with TAVR for the combined endpoints of death from any cause, stroke and rehospitalization (hospitalization related to biological valves or procedures or heart failure) at 1 year postoperatively. Patients will be seen for follow-up visits at discharge, 30 days, and annually through 10 years.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
800
SAVR
TAVR
Composite endpoint of all-cause mortality, all stroke, and rehospitalization (valve-related or procedure-related and including heart failure)
Time frame: at 1 year post procedure
the rate of all-cause mortality or disabling stroke
Time frame: at one year
the rate of all-cause mortality
Time frame: at one year
the rate of all stroke
Time frame: at one year
the rate of disabling stroke
Time frame: at one year
the rate of rehospitalization (valve-related or procedure-related and including heart failure)
Time frame: at one year
the rate of new bundle branch block or new pacemaker implantation
Time frame: at one year
the rate of new onset of atrial fibrillation
Time frame: at 30 days
the rate of life-threatening bleeding
Time frame: at one year
the rate of occurrence of perivalvular regurgitation ≥ mild by echocardiography
Time frame: at one year
Quality of life as assessed by KCCQ
Time frame: at one year
Shigeru Miyagawa, M.D.
CONTACT
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Japanese Red Cross Aichi Medical Center Nagoya Daiichi Hospital
Nagoya, Aichi-ken, Japan
NOT_YET_RECRUITINGNew Tokyo Hospital
Matsudo, Chiba, Japan
RECRUITINGChibanishi General Hospital
Matsudo, Chiba, Japan
RECRUITINGTokyo Bay Urayasu Ichikawa Medical Center
Urayasu, Chiba, Japan
RECRUITINGFukui Cardiovascular center
Fukui-shi, Fukui, Japan
NOT_YET_RECRUITINGKyushu Univerisity
Fukuoka, Fukuoka, Japan
RECRUITINGKokura Memorial Hospital
Kitakyushu, Fukuoka, Japan
RECRUITINGKurume University
Kurume, Fukuoka, Japan
RECRUITINGHyogo Medical University
Nishinomiya, Hyōgo, Japan
RECRUITINGKagoshima Medical Center
Kagoshima, Kagoshima-ken, Japan
NOT_YET_RECRUITING...and 27 more locations
Quality of life as assessed by EQ-5D-5L
Time frame: at one year
the rate of prosthetic valve endocarditis
Time frame: at one year
the rate of prosthetic valve thrombosis
Time frame: at one year
the rate of valve-related dysfunction requiring repeat procedure
Time frame: at one year