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Aortic StenosisAMETHYSTNCT06924151

Isolated Surgical Aortic Valve Replacement in Low Risk AS Patients

A study testing surgical aortic valve replacement and Transcatheter aortic valve replacement in people with Aortic Stenosis, run by Osaka University at 37 sites in Japan.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

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. Read more about this study

Who is it for?
Any age
Conditions the study is for
Aortic Stenosis
What is being tested?
surgical aortic valve replacement and Transcatheter aortic valve replacement
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
450 participants
Where
37 sitesJapan
Study dates
1 Jun 2025to 31 May 2040
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Any age
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • All study participants must meet the following inclusion criteria 1. Severe, calcific aortic stenosis with the following criteria:
  • Jet velocity ≥4.0 m/s or mean gradient ≥ 40 mmHg OR
  • AVA ≤1.0 cm2 or AVA index ≤ 0.6 cm2/m2 Note: Qualifying TTE must be within 90 days prior to randomization
  • AND 2. NYHA class ≥ II OR Exercisee test that demonstrates a limited exercise capacity, abnormal blood pressure response, or arrhythmia OR Asymptomatic patients with LVEF <50%
  • The Heart Team agrees that the surgical mortality risk is less than 4% according to STS-PROM. The Heart Team's assessment should include evaluation of overall clinical status and comorbidities that may not be adequately captured by risk calculators such as STS-PROM, in addition to the risk score itself.
  • The patient has been informed of the nature of the study, agrees to its provisions and has provided written informed consent as approved by certified review board.

Who cannot join

  • Candidates will be excluded from the study if any of the following conditions are present:
  • History of cardiovascular surgery or thoracotomy
  • Pre-existing other valvular disease, coronary artery disease or aortic disease required intervention Note: interventions for arrhythmia or root enlargement are not considered exclusionary.
  • Heart Team assessment that chest abnormalities or significant frailty would prevent safe SAVR.
  • Native aortic annulus size unsuitable for sizes the currently approved and marketed SAVR or TAVR based on preoperative 3D-CT image analysis.
  • Iliofemoral vessel characteristics that whould preclude safe insertion of the introducer sheath.
Show all 36Show fewer
  • Evidence of an acute myocardial infarction or PCI ≤ 30 days before randomization
  • Aortic valve is unicuspid
  • Severe aortic regurgitation (>3+)
  • Severe mitral regurgitation (>3+) or ≥ moderate stenosis
  • Severe tricuspid regurgitation (>3+) or ≥ moderate stenosis
  • Pre-existing mechanical or bioprosthetic valve in any position.
  • Complex coronary artery disease:
  • Heart Team assessment that CABG is recommended at the time of SAVR
  • Heart Team assessment that optimal revascularization cannot be performed
  • Symptomatic carotid or vertebral artery disease or treatment of carotid stenosis within 30 days of randomization
  • Leukopenia (WBC < 3000 cell/mL), Thrombocytopenia (Plt < 50,000 cell/mL), history of bleeding diathesis or coagulopathy.
  • Hemodynamic or respiratory instability requiring inotropic support, mechanical ventilation or mechanical heart assistance within 30 days of randomization
  • Hypertrophic cardiomyopathy with obstruction (HOCM)
  • Ventricular dysfunction with LVEF < 30%
  • Cardiac imaging (echo, CT, and/or MRI) evidence of intracardiac mass, thrombus or vegetation
  • Inability to tolerate or condition precluding treatment with antithrombotic/anticoagulation therapy during or after the valve implant procedure
  • Stroke or transient ischemic attack (TIA) within 90 days of randomization
  • Renal insufficiency (eGFR < 30 ml/min per the Cockcroft-Gault formula) and/or renal replacement therapy
  • Active bacterial endocarditis within 180 days of randomization
  • Severe lung disease (FEV1 < 50% predicted) or currently on home oxygen
  • Severe pulmonary hypertension (e.g., PA systolic pressure ≥ 2/3 systemic pressure)
  • History of cirrhosis or active liver disease
  • Significant abdominal or thoracic aortic disease (such as porcelain aorta, aneurysm, severe calcification, aortic coarctation, etc.) that would preclude cannulation and aortotomy for SAVR or safe passage of the delivery system for TAVR.
  • Patient refuses blood products.
  • BMI > 50 kg/m2
  • Estimated life expectancy < 24 months.
  • Absolute contraindications or allergy to iodinated contrast that cannot be adequately treated with pre-medication.
  • Immobility or significant cognitive impairment that would prevent completion of study procedure.
  • Currently participating in an investigational drug or another device study.
  • Unsuitable as candidates by the principal investigator or a research associate for other reasons

Trial locations and contacts

37 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Shigeru Miyagawa, M.D. contact

37 sites in 1 country

Japan37 sites, 37 recruiting
  • Kansai Rosai Hospital

    Amagasaki

    Mutsunori Kitahara, M.D., 81-6-6416-1221, mkitahara119@gmail.com

    Mutsunori Kitahara, M.D.

    Recruiting
  • Sakakibara Heart Institute

    Fuchū, Tokyo, 1830003

    Tomohiro Iwakura, M.D., +81423143111, tomalex5050@gmail.com

    Tomohiro Iwakura, M.D.

    Recruiting
  • Kyushu Univerisity

    Fukuoka, 8128582

    Akira Shiose, M.D., +81926411151, shiose.akira.799@m.kyushu-u.ac.jp

    Akira Shiose, M.D.

    Recruiting
  • Seirei Hamamatsu General Hospital

    Hamamatsu, Shizuoka, 4308558

    Masaaki Koide, M.D., +81534742222, mkoide@sis.seirei.or.jp

    Masaaki Koide, M.D.

    Recruiting
  • Hamamatsu University Shool of Medicine

    Hamamatsu, Shizuoka, 4313192

    Kazuma Okamoto, M.D., +81534352111, okamoto@hama-med.ac.jp

    Kazuma Okamoto, M.D.

    Recruiting
  • Saitama Medical University International Medical Center

    Hidaka, Saitama, 3501298

    Akihiro Yoshitake, M.D., +81429844111, akihiro197253@yahoo.co.jp

    Akihiro Yoshitake, M.D.

    Recruiting
  • Tokai University

    Isehara, Kanagawa, 2591193

    Yohei Ohno, M.D., +81463931121, yohno@tokai.ac.jp

    Yohei Ohno, M.D.

    Recruiting
  • Shonan Kamakura General Hospital

    Kamakura, Kanagawa, 2478533

    Shigeru Saito, M.D., +81467461717, transradial@kamakuraheart.org

    Shigeru Saito, M.D.

    Recruiting
  • Kawasakisaiwai Hospital

    Kawasaki, Kanagawa, 2120014

    Shuichiro Takanashi, M.D., +81445444611, s0715t@gmail.com

    Shuichiro Takanashi, M.D.

    Recruiting
  • St.Marianna University School of Medicine

    Kawasaki, Kanagawa, 2168511

    Kan Nawata, M.D., +81449778111, kan.nawata@marianna-u.ac.jp

    Kan Nawata, M.D.

    Recruiting
  • Kishiwada Tokusyukai Hospital

    Kishiwada, Osaka, 5960042

    Satoshi Kuroyanagi, M.D., +81724459915, satoshi_5023@yahoo.co.jp

    Satoshi Kuroyanagi, M.D.

    Recruiting
  • Kokura Memorial Hospital

    Kitakyushu, Fukuoka, 802-8555

    Shinichi Shirai, M.D., +81935112000, shirai440130@gmail.com

    Shinichi Shirai, M.D.

    Recruiting
  • Chikamori Hospital

    Kochi, 7808522

    Hiroyuki Irie, M.D., +81888225231, irie@chikamori.com

    Hiroyuki Irie, M.D.

    Recruiting
  • Kumamoto University

    Kumamoto, 8608556

    Kenichi Tsujita, M.D., +81963735025, tsujita@kumamoto-u.ac.jp

    Kenichi Tsujita, M.D.

    Recruiting
  • Kurume University

    Kurume, Fukuoka, 8300011

    Tohru Takaseya, M.D., +81942353311, ttakaseya@kurume-u.ac.jp

    Tohru Takaseya, M.D.

    Recruiting
  • New Tokyo Hospital

    Matsudo, Chiba, 2402232

    Tatsuya Nakao, M.D., +81-47-711-8700, data-management@shin-tokyohospital.or.jp

    Tatsuya Nakao, M.D.

    Recruiting
  • Chibanishi General Hospital

    Matsudo, Chiba, 2702251

    Yoshitsugu Nakamura, M.D., +81473848111, ystgnkmr@gmail.com

    Yoshitsugu Nakamura, M.D.

    Recruiting
  • Shinshu University

    Matsumoto, Nagano, 3908621

    Tatsuichiro Seto, M.D., +81570003010, seto@shinshu-u.ac.jp

    Tatsuichiro Seto, M.D.

    Recruiting
  • Nagasaki University

    Nagasaki, 8528501

    Takashi Miura, M.D., +81958197200, takashirsa@nagasaki-u.ac.jp

    Takashi Miura, M.D.

    Recruiting
  • Niigata University Medical and Dental Hospital

    Niigata, 951-8520

    Makoto Hoyano, M.D., 025-223-6161, mhoyano@med.niigata-u.ac.jp

    Makoto Hoyano, M.D.

    Recruiting
  • Hyogo Medical University

    Nishinomiya, Hyōgo, 6638501

    Kenichi Watanabe, M.D., +817989456111, kenichi217@yahoo.co.jp

    Kenichi Watanabe, M.D.

    Recruiting
  • Oita University

    Ōita, Yufu, 879-5593

    Takashi Syuto, M.D., +8197-549-4411, shutot@oita-u.ac.jp

    Takashi Syuto, M.D.

    Recruiting
  • The Sakakibara Heart Institute of Okayama

    Okayama, 7000804

    Arudo Hiraoka, M.D., 81862257111, bassbord1028@yahoo.co.jp

    Arudo Hiraoka, M.D.

    Recruiting
  • Osaka International Medical and Science Center

    Osaka, 5438922

    Yoshiki Sawa, M.D., +81667716051, yshksw2@gmail.com

    Yoshiki Sawa, M.D.

    Recruiting
  • Osaka General Medical Center

    Osaka, 558-8558

    Naosumi Sekiya, M.D., 06-6692-1201, sekiyan73@gmail.com

    Naosumi Sekiya, M.D.

    Recruiting
  • National Hospital Organization Osaka National Hospital

    Osaka

    Tetsuya Saito, M.D., 81-6-6942-1331, saito.tetsuya.nj@mail.hosp.go.jp

    Tetsuya Saito, M.D.

    Recruiting
  • Osaka Rosai Hospital

    Sakai, Osaka, 591-8025

    Haruhiko Kondoh, M.D., 072-252-3561, haruhk@wa3.so-net.ne.jp

    Haruhiko Kondoh, M.D.

    Recruiting
  • Kinki University Hospital

    Sayama, Osaka, 589-8511

    Gaku Nakazawa, M.D., +8172366-0221, gnakazawa@med.kindai.ac.jp

    Gaku Nakazawa, M.D.

    Recruiting
  • Dokkyo Medical University

    Shimotsuga, Tochigi, 3210293

    Masashi Kawamura, M.D., +81282861111, m-kawamura129@dokkyomed.ac.jp

    Masashi Kawamura, M.D.

    Recruiting
  • Tokyo Women's Medical University

    Shinjuku, Tokyo, 1628666

    Hiroshi Niinami, M.D., +81333538111, hniinami@twmu.ac.jp

    Hiroshi Niinami, M.D.

    Recruiting
  • Shizuoka General Hospital

    Shizuoka, 4208527

    Hiroshi Tsuneyoshi, M.D., +8154-247-6111, tuneyosi_ca@yahoo.co.jp

    Hiroshi Tsuneyoshi, M.D.

    Recruiting
  • National cerebral and cardiovascular center

    Suita

    Satsuki Fukushima, M.D., 81-6-6170-1070, s.fukushima@ncvc.go.jp

    Satsuki Fukushima, M.D.

    Recruiting
  • Tokushima University

    Tokushima, 7708503

    Hiroki Hata, M.D., +8188-631-3111, hatahiro@tokushima-u.ac.jp

    Hiroki Hata, M.D.

    Recruiting
  • Yuuai Medical Center

    Tomigusuku, Okinawa, 9010224

    Akihiko Yamauchi, 0988503811, yamauchi4964@gmail.com

    Akihiko Yamauchi, M.D.

    Recruiting
  • Tokyo Bay Urayasu Ichikawa Medical Center

    Urayasu, Chiba, 2790001

    Kunihiko Yoshino, M.D., +8147-351-3101, kyoshino36@gmail.com

    Kunihiko Yoshino, M.D.

    Recruiting
  • Wakayama Medical University

    Wakayama, 6418509

    Kentaro Honda, M.D., +81734472300, honda-k@wakayama-med.ac.jp

    Kentaro Honda, M.D.

    Recruiting
  • Tottori University

    Yonago, Tottori, 6838504

    Yasushi Yoshikawa, M.D., +81859331111, yoshikawa@tottori-u.ac.jp

    Yasushi Yoshikawa, M.D.

    Recruiting

Other trials in Japan

About this study

Official title: the Prospective, Randomized, Controlled, Multi-center Study to Establish the Safety and Effectiveness of Isolated Surgical Aortic Valve Replacement in Low Risk Patients Who Have Symptomatic Severe Aortic Stenosis

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.

Read the detailed description

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.

Conditions
Aortic Stenosis
Being tested
surgical aortic valve replacement, Transcatheter aortic valve replacement
Medical subject headings
Aortic Valve Stenosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • surgical aortic valve replacementProcedure or surgery

    SAVR

  • Transcatheter aortic valve replacementProcedure or surgery

    TAVR

Study groups in NCT06924151
Study groupRoleWhat they receive
Surgical aortic valve replacementExperimentalSurgical aortic valve replacement (SAVR) with free choice of surgical bioprosthesis and free choice of surgical access according to the surgeon's preference
Receives: Procedure: surgical aortic valve replacement
Transcatheter aortic valve replacementActive comparatorTranscatheter aortic valve replacement (TAVR) using the device available in Japan in facilities approved to perform TAVR.
Receives: Procedure: Transcatheter aortic valve replacement

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Composite endpoint of all-cause mortality, all stroke, and rehospitalization (valve-related or procedure-related and including heart failure)

    Measured: at 1 year post procedure

Secondary outcomes (14)
  1. the rate of all-cause mortality or disabling stroke

    Measured: at one year

  2. the rate of all-cause mortality

    Measured: at one year

  3. the rate of all stroke

    Measured: at one year

  4. the rate of disabling stroke

    Measured: at one year

  5. the rate of rehospitalization (valve-related or procedure-related and including heart failure)

    Measured: at one year

  6. the rate of new bundle branch block or new pacemaker implantation

    Measured: at one year

  7. the rate of new onset of atrial fibrillation

    Measured: at 30 days

  8. the rate of life-threatening bleeding

    Measured: at one year

  9. the rate of occurrence of perivalvular regurgitation ≥ mild by echocardiography

    Measured: at one year

  10. Quality of life as assessed by KCCQ

    Measured: at one year

  11. Quality of life as assessed by EQ-5D-5L

    Measured: at one year

  12. the rate of prosthetic valve endocarditis

    Measured: at one year

  13. the rate of prosthetic valve thrombosis

    Measured: at one year

  14. the rate of valve-related dysfunction requiring repeat procedure

    Measured: at one year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Apr 2025
  2. Study start1 Jun 2025
  3. Primary completion31 May 2031 (estimated)
  4. Study completion31 May 2040 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
450 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06924151
Sponsor's protocol ID
AMETHYST-001
Acronym
AMETHYST
Status last verified
Jun 2026
First submitted
11 Feb 2025
Last updated
4 Sep 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing surgical aortic valve replacement and Transcatheter aortic valve replacement in people with Aortic Stenosis, run by Osaka University at 37 sites in Japan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 36 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 4 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 37 sites in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Koichi Maeda, M.D. (+81 -6-6879-3154, k-maeda@surg1.med.osaka-u.ac.jp), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Sep 2026.

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