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Recruiting Not applicable

Isolated Surgical Aortic Valve Replacement in Low Risk AS Patients

NCT06924151 · tracked via the Priya Life Science Japan tracker
Phase
Not applicable
Started
2025-06-01
Last updated
2026-09-04

Condition(s) studied

Aortic Stenosis

Investigational drug(s) / intervention(s)

surgical aortic valve replacementTranscatheter aortic valve replacement

surgical aortic valve replacement: SAVR

Transcatheter aortic valve replacement: TAVR

Study 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.

Eligibility

Sex
ALL
Min age
—
Max age
—
Healthy volunteers
No
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

Primary outcome measure(s)

  • Composite endpoint of all-cause mortality, all stroke, and rehospitalization (valve-related or procedure-related and including heart failure) — at 1 year post procedure

Trial sites (37)

FacilityCityRegionStatus
New Tokyo Hospital Matsudo Chiba Recruiting
Chibanishi General Hospital Matsudo Chiba Recruiting
Tokyo Bay Urayasu Ichikawa Medical Center Urayasu Chiba Recruiting
Kokura Memorial Hospital Kitakyushu Fukuoka Recruiting
Kurume University Kurume Fukuoka Recruiting
Hyogo Medical University Nishinomiya Hyōgo Recruiting
Tokai University Isehara Kanagawa Recruiting
Shonan Kamakura General Hospital Kamakura Kanagawa Recruiting
Kawasakisaiwai Hospital Kawasaki Kanagawa Recruiting
St.Marianna University School of Medicine Kawasaki Kanagawa Recruiting
Shinshu University Matsumoto Nagano Recruiting
Yuuai Medical Center Tomigusuku Okinawa Recruiting
Kishiwada Tokusyukai Hospital Kishiwada Osaka Recruiting
Osaka Rosai Hospital Sakai Osaka Recruiting
Kinki University Hospital Sayama Osaka Recruiting
Saitama Medical University International Medical Center Hidaka Saitama Recruiting
Seirei Hamamatsu General Hospital Hamamatsu Shizuoka Recruiting
Hamamatsu University Shool of Medicine Hamamatsu Shizuoka Recruiting
Dokkyo Medical University Shimotsuga Tochigi Recruiting
Sakakibara Heart Institute Fuchū Tokyo Recruiting
Tokyo Women's Medical University Shinjuku Tokyo Recruiting
Tottori University Yonago Tottori Recruiting
Oita University Ōita Yufu Recruiting
Kansai Rosai Hospital Amagasaki Japan Recruiting
Kyushu Univerisity Fukuoka Japan Recruiting
Chikamori Hospital Kochi Japan Recruiting
Kumamoto University Kumamoto Japan Recruiting
Nagasaki University Nagasaki Japan Recruiting
Niigata University Medical and Dental Hospital Niigata Japan Recruiting
The Sakakibara Heart Institute of Okayama Okayama Japan Recruiting
Osaka International Medical and Science Center Osaka Japan Recruiting
Osaka General Medical Center Osaka Japan Recruiting
National Hospital Organization Osaka National Hospital Osaka Japan Recruiting
Shizuoka General Hospital Shizuoka Japan Recruiting
National cerebral and cardiovascular center Suita Japan Recruiting
Tokushima University Tokushima Japan Recruiting
Wakayama Medical University Wakayama Japan Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06924151 on ClinicalTrials.gov ↗ ← All trials in Japan