Clinical Trials in Japan / NCT06924151
Recruiting
Not applicable
Isolated Surgical Aortic Valve Replacement in Low Risk AS Patients
NCT06924151 · tracked via the Priya Life Science Japan tracker
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
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)
| Facility | City | Region | Status |
|---|---|---|---|
| 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 |
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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