Isolated Surgical Aortic Valve Replacement in Low Risk AS Patients

Launched by OSAKA UNIVERSITY · Apr 4, 2025

Keywords

ClinConnect Summary

This clinical trial is looking at the safety and effectiveness of a procedure called surgical aortic valve replacement (SAVR) for patients with severe aortic stenosis who are considered to be at low risk for surgery. Aortic stenosis is a condition where the heart's aortic valve becomes narrowed, making it harder for the heart to pump blood. The trial will include patients who have specific measurements indicating severe aortic stenosis and who are experiencing some symptoms or have a weakened heart function.

To qualify for the study, participants must have severe narrowing of the aortic valve and be assessed by a medical team to ensure their risk of surgery is low. They should also agree to take part in the study and provide written consent. If someone is interested in joining the trial, they will undergo evaluations to confirm their eligibility, and if accepted, they can expect to receive close medical supervision throughout the process. It’s important to note that certain health conditions may prevent someone from participating, such as having a history of heart surgery or other serious heart issues.

Gender

ALL

Eligibility 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