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Surgical aortic valve replacement versus TAVR for low-risk severe aortic stenosis

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

Not applicable Interventional Osaka University · NCT06924151

This study tests whether surgical aortic valve replacement or transcatheter aortic valve replacement (TAVR) gives better safety and outcomes for people with severe, calcific aortic stenosis who are at low surgical risk.

Quick facts

PhaseNot applicable
Study typeInterventional
Enrollment800 (estimated)
SexAll
SponsorOsaka University Academic / other
Locations37 sites (Nagoya, Aichi-ken and 36 other locations)
Trial IDNCT06924151 on ClinicalTrials.gov

What this trial studies

In this multicenter, randomized study in Japan, eligible patients with isolated severe calcific aortic stenosis and low predicted surgical mortality are randomized 1:1 to receive either surgical aortic valve replacement (SAVR) or transcatheter aortic valve replacement (TAVR) with commercially available bioprosthetic valves. The main goal is to test non-inferiority of SAVR versus TAVR for a composite outcome of all-cause death, stroke, and rehospitalization related to valves, procedures, or heart failure at one year. Participants are seen at discharge, 30 days, and annually through 10 years to capture both short- and long-term outcomes and valve performance. A Heart Team must confirm surgical mortality risk under 4% (STS-PROM) and qualifying echocardiography must document severe AS.

Who should consider this trial

Good fit: Adults with isolated severe, calcific aortic stenosis who meet echocardiographic criteria and are judged by a Heart Team to have low surgical mortality risk (STS-PROM <4%) and who are symptomatic (NYHA II or higher), have limited exercise capacity, or have LVEF <50% are ideal candidates.

Not a fit: Patients with higher predicted surgical mortality (STS-PROM ≥4%), significant comorbidities that preclude surgery, non-calcific valve pathology, or inability to attend the participating Japanese centers are unlikely to benefit or be eligible.

Why it matters

Potential benefit: If successful, the results could help patients and clinicians choose between SAVR and TAVR for low-risk severe aortic stenosis and provide clearer data on long-term outcomes for surgical valves.

How similar studies have performed: Previous large randomized trials in low-risk patients (for example PARTNER 3 and Evolut Low Risk) have shown TAVR can be non-inferior to SAVR, so this study builds on established findings.

Eligibility criteria

Show full inclusion / exclusion criteria 
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

Where this trial is running

Nagoya, Aichi-ken and 36 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Aortic Stenosis
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.