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RECRUITINGINTERVENTIONAL

Isolated Surgical Aortic Valve Replacement in Low Risk AS Patients

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

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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.

Who May Be Eligible (Plain English)

Who May Qualify: 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 willing to sign a consent form as approved by certified review board. Who Should NOT Join This Trial: 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 ...See full criteria on ClinicalTrials.gov Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
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

Treatments Being Tested

PROCEDURE

surgical aortic valve replacement

SAVR

PROCEDURE

Transcatheter aortic valve replacement

TAVR

Locations (20)

Japanese Red Cross Aichi Medical Center Nagoya Daiichi Hospital
Nagoya, Aichi-ken, Japan
New Tokyo Hospital
Matsudo, Chiba, Japan
Chibanishi General Hospital
Matsudo, Chiba, Japan
Tokyo Bay Urayasu Ichikawa Medical Center
Urayasu, Chiba, Japan
Fukui Cardiovascular center
Fukui-shi, Fukui, Japan
Kyushu Univerisity
Fukuoka, Fukuoka, Japan
Kokura Memorial Hospital
Kitakyushu, Fukuoka, Japan
Kurume University
Kurume, Fukuoka, Japan
Hyogo Medical University
Nishinomiya, Hyōgo, Japan
Kagoshima Medical Center
Kagoshima, Kagoshima-ken, Japan
Tokai University
Isehara, Kanagawa, Japan
Shonan Kamakura General Hospital
Kamakura, Kanagawa, Japan
Kawasakisaiwai Hospital
Kawasaki, Kanagawa, Japan
St.Marianna University School of Medicine
Kawasaki, Kanagawa, Japan
Chikamori Hospital
Kochi, Kochi, Japan
Kumamoto University
Kumamoto, Kumamoto, Japan
Shinshu University
Matsumoto, Nagano, Japan
Nagasaki University
Nagasaki, Nagasaki, Japan
Niigata University Medical and Dental Hospital
Niigata, Niigata, Japan
The Sakakibara Heart Institute of Okayama
Okayama, Okayama-ken, Japan