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Recruiting
NCT06924151
Isolated Surgical Aortic Valve Replacement in Low Risk AS Patients
Conditions: Aortic Stenosis
Sex: All
Healthy volunteers: No
Phase: NA
Enrollment: 450
Sponsor: Osaka University
Location: New Tokyo Hospital Matsudo Chiba
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 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 \
Source: ClinicalTrials.gov (NCT06924151). StuddyBuddy aggregates publicly available trial information.