Isolated Surgical Aortic Valve Replacement in Low Risk AS Patients

Recruiting N/A Interventional Study
Aortic Stenosis
No Placebo Group Every participant receives an active treatment — no one gets a placebo.
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At a Glance
Sex
Any
Study type
Interventional
Purpose
Treatment
Participants needed
800 (estimated)
Sponsor
Osaka University · Other
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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.

Trial Locations
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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…
Contacts

Koichi Maeda, M.D.

+81 -6-6879-3154

k-maeda@surg1.med.osaka-u.ac.jp

CONTACT

Shigeru Miyagawa, M.D.

CONTACT