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Can Open-Heart surgery outperform a Tube-Based valve fix?

NCT ID NCT06924151

Disease control Sponsor: Osaka University Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Sep 04, 2026 · Last updated Sep 04, 2026

Summary

This trial tests whether traditional open-heart surgery to replace a narrowed aortic valve works as well as a less invasive catheter-based approach in patients with severe aortic stenosis who are otherwise at low surgical risk. Researchers will compare rates of death, stroke, and repeat hospital stays over time. The goal is to help doctors and patients choose the best valve replacement method based on solid evidence.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
surgical aortic valve replacement (SAVR) compared with transcatheter aortic valve replacement (TAVR)
What this could lead to
If SAVR proves safe and effective in low-risk patients, it could confirm surgery as a strong first-choice option for severe aortic stenosis, potentially reducing complications and repeat hospital stays.
What could go wrong
The trial is still gathering evidence, and results may not favor surgery over the less invasive TAVR. Surgery carries risks like stroke, bleeding, and infection, and outcomes depend on patient health and surgeon experience.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 450 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jun 2025

Expected to finish

May 2040

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

Children (under 18), adults (18 to 64) and older adults (65 and over)

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. 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% 2. 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. 3. 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. Exclusion Criteria: Candidates will be excluded from the study if any of the following conditions are present: 1. History of cardiovascular surgery or thoracotomy 2. Pre-existing other valvular disease, coronary artery disease or aortic disease required intervention Note: interventions for arrhythmia or root enlargement are not considered exclusionary. 3. Heart Team assessment that chest abnormalities or significant frailty would prevent safe SAVR. 4. Native aortic annulus size unsuitable for sizes the currently approved and marketed SAVR or TAVR based on preoperative 3D-CT image analysis. 5. Iliofemoral vessel characteristics that whould preclude safe insertion of the introducer sheath. 6. Evidence of an acute myocardial infarction or PCI ≤ 30 days before randomization 7. Aortic valve is unicuspid 8. Severe aortic regurgitation (\>3+) 9. Severe mitral regurgitation (\>3+) or ≥ moderate stenosis 10. Severe tricuspid regurgitation (\>3+) or ≥ moderate stenosis 11. Pre-existing mechanical or bioprosthetic valve in any position. 12. Complex coronary artery disease: 1. Heart Team assessment that CABG is recommended at the time of SAVR 2. Heart Team assessment that optimal revascularization cannot be performed 13. Symptomatic carotid or vertebral artery disease or treatment of carotid stenosis within 30 days of randomization 14. Leukopenia (WBC \< 3000 cell/mL), Thrombocytopenia (Plt \< 50,000 cell/mL), history of bleeding diathesis or coagulopathy. 15. Hemodynamic or respiratory instability requiring inotropic support, mechanical ventilation or mechanical heart assistance within 30 days of randomization 16. Hypertrophic cardiomyopathy with obstruction (HOCM) 17. Ventricular dysfunction with LVEF \< 30% 18. Cardiac imaging (echo, CT, and/or MRI) evidence of intracardiac mass, thrombus or vegetation 19. Inability to tolerate or condition precluding treatment with antithrombotic/anticoagulation therapy during or after the valve implant procedure 20. Stroke or transient ischemic attack (TIA) within 90 days of randomization 21. Renal insufficiency (eGFR \< 30 ml/min per the Cockcroft-Gault formula) and/or renal replacement therapy 22. Active bacterial endocarditis within 180 days of randomization 23. Severe lung disease (FEV1 \< 50% predicted) or currently on home oxygen 24. Severe pulmonary hypertension (e.g., PA systolic pressure ≥ 2/3 systemic pressure) 25. History of cirrhosis or active liver disease 26. 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. 27. Patient refuses blood products. 28. BMI \> 50 kg/m2 29. Estimated life expectancy \< 24 months. 30. Absolute contraindications or allergy to iodinated contrast that cannot be adequately treated with pre-medication. 31. Immobility or significant cognitive impairment that would prevent completion of study procedure. 32. Currently participating in an investigational drug or another device study. 33. Unsuitable as candidates by the principal investigator or a research associate for other reasons

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Conditions

The condition(s) this trial relates to.

aortic valve stenosis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Aortic stenosis

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    37 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Chibanishi General Hospital

    RECRUITING

    Matsudo, Chiba, 2702251, Japan

  • Chikamori Hospital

    RECRUITING

    Kochi, 7808522, Japan

  • Dokkyo Medical University

    RECRUITING

    Shimotsuga, Tochigi, 3210293, Japan

  • Hamamatsu University Shool of Medicine

    RECRUITING

    Hamamatsu, Shizuoka, 4313192, Japan

  • Hyogo Medical University

    RECRUITING

    Nishinomiya, Hyōgo, 6638501, Japan

  • Kansai Rosai Hospital

    RECRUITING

    Amagasaki, Japan

  • Kawasakisaiwai Hospital

    RECRUITING

    Kawasaki, Kanagawa, 2120014, Japan

  • Kinki University Hospital

    RECRUITING

    Sayama, Osaka, 589-8511, Japan

  • Kishiwada Tokusyukai Hospital

    RECRUITING

    Kishiwada, Osaka, 5960042, Japan

  • Kokura Memorial Hospital

    RECRUITING

    Kitakyushu, Fukuoka, 802-8555, Japan

  • Kumamoto University

    RECRUITING

    Kumamoto, 8608556, Japan

  • Kurume University

    RECRUITING

    Kurume, Fukuoka, 8300011, Japan

  • Kyushu Univerisity

    RECRUITING

    Fukuoka, 8128582, Japan

  • Nagasaki University

    RECRUITING

    Nagasaki, 8528501, Japan

  • National Hospital Organization Osaka National Hospital

    RECRUITING

    Osaka, Japan

  • National cerebral and cardiovascular center

    RECRUITING

    Suita, Japan

  • New Tokyo Hospital

    RECRUITING

    Matsudo, Chiba, 2402232, Japan

  • Niigata University Medical and Dental Hospital

    RECRUITING

    Niigata, 951-8520, Japan

  • Oita University

    RECRUITING

    Ōita, Yufu, 879-5593, Japan

  • Osaka General Medical Center

    RECRUITING

    Osaka, 558-8558, Japan

  • Osaka International Medical and Science Center

    RECRUITING

    Osaka, 5438922, Japan

  • Osaka Rosai Hospital

    RECRUITING

    Sakai, Osaka, 591-8025, Japan

  • Saitama Medical University International Medical Center

    RECRUITING

    Hidaka, Saitama, 3501298, Japan

  • Sakakibara Heart Institute

    RECRUITING

    Fuchū, Tokyo, 1830003, Japan

  • Seirei Hamamatsu General Hospital

    RECRUITING

    Hamamatsu, Shizuoka, 4308558, Japan

  • Shinshu University

    RECRUITING

    Matsumoto, Nagano, 3908621, Japan

  • Shizuoka General Hospital

    RECRUITING

    Shizuoka, 4208527, Japan

  • Shonan Kamakura General Hospital

    RECRUITING

    Kamakura, Kanagawa, 2478533, Japan

  • St.Marianna University School of Medicine

    RECRUITING

    Kawasaki, Kanagawa, 2168511, Japan

  • The Sakakibara Heart Institute of Okayama

    RECRUITING

    Okayama, 7000804, Japan

  • Tokai University

    RECRUITING

    Isehara, Kanagawa, 2591193, Japan

  • Tokushima University

    RECRUITING

    Tokushima, 7708503, Japan

  • Tokyo Bay Urayasu Ichikawa Medical Center

    RECRUITING

    Urayasu, Chiba, 2790001, Japan

  • Tokyo Women's Medical University

    RECRUITING

    Shinjuku, Tokyo, 1628666, Japan

  • Tottori University

    RECRUITING

    Yonago, Tottori, 6838504, Japan

  • Wakayama Medical University

    RECRUITING

    Wakayama, 6418509, Japan

  • Yuuai Medical Center

    RECRUITING

    Tomigusuku, Okinawa, 9010224, Japan

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