Actively Recruiting
Isolated Surgical Aortic Valve Replacement in Low Risk AS Patients
Led by Osaka University · Updated on 2025-08-28
800
Participants Needed
37
Research Sites
626 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Isolated Surgical Aortic Valve Replacement in Low Risk AS Patients
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Severe, calcific aortic stenosis with jet velocity ≥4.0 m/s or mean gradient ≥40 mmHg OR aortic valve area ≤1.0 cm² or indexed area ≤0.6 cm²/m² within 90 days prior to randomization
- New York Heart Association class II or higher symptoms OR limited exercise capacity, abnormal blood pressure, or arrhythmia on exercise test OR asymptomatic with left ventricular ejection fraction below 50%
- Heart Team assessment indicating surgical mortality risk less than 4% according to STS-PROM and clinical evaluation
- Patient informed about the study, agrees to participate, and has provided written informed consent
You will not qualify if you...
- History of cardiovascular surgery or thoracotomy
- Other valvular disease, coronary artery disease, or aortic disease requiring intervention (except arrhythmia or root enlargement procedures)
- Chest abnormalities or significant frailty preventing safe surgical aortic valve replacement
- Unsuitable native aortic annulus size for approved SAVR or TAVR devices
- Iliofemoral vessel features preventing safe introducer sheath insertion
- Acute myocardial infarction or percutaneous coronary intervention within 30 days before randomization
- Unicuspid aortic valve
- Severe aortic, mitral, or tricuspid regurgitation or moderate stenosis
- Presence of pre-existing mechanical or bioprosthetic heart valve
- Complex coronary artery disease requiring bypass surgery or not amenable to optimal revascularization
- Symptomatic carotid or vertebral artery disease or carotid stenosis treatment within 30 days
- Blood disorders such as leukopenia, thrombocytopenia, bleeding diathesis, or coagulopathy
- Hemodynamic or respiratory instability requiring inotropic support, mechanical ventilation, or heart assistance within 30 days
- Hypertrophic obstructive cardiomyopathy
- Left ventricular ejection fraction below 30%
- Intracardiac mass, thrombus, or vegetation on imaging
- Inability to tolerate antithrombotic or anticoagulation therapy
- Stroke or transient ischemic attack within 90 days
- Severe renal insufficiency or on renal replacement therapy
- Active bacterial endocarditis within 180 days
- Severe lung disease or home oxygen use
- Severe pulmonary hypertension
- History of cirrhosis or active liver disease
- Significant aortic disease impeding surgery or device delivery
- Patient refusal of blood products
- Body mass index over 50 kg/m²
- Estimated life expectancy less than 24 months
- Absolute contraindications or allergy to iodinated contrast not manageable by pre-medication
- Immobility or cognitive impairment preventing study procedures
- Participation in another investigational drug or device study
- Deemed unsuitable by principal investigator or research associate for other reasons
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 37 locations
1
Japanese Red Cross Aichi Medical Center Nagoya Daiichi Hospital
Nagoya, Aichi-ken, Japan, 4538511
Not Yet Recruiting
2
New Tokyo Hospital
Matsudo, Chiba, Japan, 2402232
Actively Recruiting
3
Chibanishi General Hospital
Matsudo, Chiba, Japan, 2702251
Actively Recruiting
4
Tokyo Bay Urayasu Ichikawa Medical Center
Urayasu, Chiba, Japan, 2790001
Actively Recruiting
5
Fukui Cardiovascular center
Fukui-shi, Fukui, Japan, 910-0833
Not Yet Recruiting
6
Kyushu Univerisity
Fukuoka, Fukuoka, Japan, 8128582
Actively Recruiting
7
Kokura Memorial Hospital
Kitakyushu, Fukuoka, Japan, 802-8555
Actively Recruiting
8
Kurume University
Kurume, Fukuoka, Japan, 8300011
Actively Recruiting
9
Hyogo Medical University
Nishinomiya, Hyōgo, Japan, 6638501
Actively Recruiting
10
Kagoshima Medical Center
Kagoshima, Kagoshima-ken, Japan, 8920853
Not Yet Recruiting
11
Tokai University
Isehara, Kanagawa, Japan, 2591193
Actively Recruiting
12
Shonan Kamakura General Hospital
Kamakura, Kanagawa, Japan, 2478533
Actively Recruiting
13
Kawasakisaiwai Hospital
Kawasaki, Kanagawa, Japan, 2120014
Actively Recruiting
14
St.Marianna University School of Medicine
Kawasaki, Kanagawa, Japan, 2168511
Actively Recruiting
15
Chikamori Hospital
Kochi, Kochi, Japan, 7808522
Actively Recruiting
16
Kumamoto University
Kumamoto, Kumamoto, Japan, 8608556
Actively Recruiting
17
Shinshu University
Matsumoto, Nagano, Japan, 3908621
Actively Recruiting
18
Nagasaki University
Nagasaki, Nagasaki, Japan, 8528501
Actively Recruiting
19
Niigata University Medical and Dental Hospital
Niigata, Niigata, Japan, 951-8520
Actively Recruiting
20
The Sakakibara Heart Institute of Okayama
Okayama, Okayama-ken, Japan, 7000804
Actively Recruiting
21
Yuuai Medical Center
Tomigusuku, Okinawa, Japan, 9010224
Actively Recruiting
22
Kishiwada Tokusyukai Hospital
Kishiwada, Osaka, Japan, 5960042
Actively Recruiting
23
Osaka International Medical and Science Center
Osaka, Osaka, Japan, 5438922
Actively Recruiting
24
Osaka General Medical Center
Osaka, Osaka, Japan, 558-8558
Actively Recruiting
25
Osaka Rosai Hospital
Sakai, Osaka, Japan, 591-8025
Actively Recruiting
26
Kinki University Hospital
Sayama, Osaka, Japan, 589-8511
Actively Recruiting
27
Saitama Medical University International Medical Center
Hidaka, Saitama, Japan, 3501298
Actively Recruiting
28
Seirei Hamamatsu General Hospital
Hamamatsu, Shizuoka, Japan, 4308558
Actively Recruiting
29
Hamamatsu University Shool of Medicine
Hamamatsu, Shizuoka, Japan, 4313192
Actively Recruiting
30
Shizuoka General Hospital
Shizuoka, Shizuoka, Japan, 4208527
Actively Recruiting
31
Dokkyo Medical University
Shimotsuga, Tochigi, Japan, 3210293
Actively Recruiting
32
Tokushima University
Tokushima, Tokushima, Japan, 7708503
Actively Recruiting
33
Sakakibara Heart Institute
Fuchū, Tokyo, Japan, 1830003
Actively Recruiting
34
Tokyo Women's Medical University
Shinjuku, Tokyo, Japan, 1628666
Actively Recruiting
35
Tottori University
Yonago, Tottori, Japan, 6838504
Actively Recruiting
36
Wakayama Medical University
Wakayama, Wakayama, Japan, 6418509
Actively Recruiting
37
Oita University
Ōita, Yufu, Japan, 879-5593
Actively Recruiting
Research Team
K
Koichi Maeda, M.D.
CONTACT
S
Shigeru Miyagawa, M.D.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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