Status:
COMPLETED
Early Surgery Versus Conventional Treatment in Very Severe Aortic Stenosis
Lead Sponsor:
Asan Medical Center
Collaborating Sponsors:
Korean Institute of Medicine
Conditions:
Aortic Stenosis
Eligibility:
All Genders
20-80 years
Phase:
NA
Brief Summary
The optimal timing of surgical intervention remains controversial in asymptomatic patients with very severe aortic stenosis. The investigators therefore try to compare long-term clinical outcomes of e...
Detailed Description
Management of asymptomatic patients with severe aortic stenosis (AS) remains controversial, and the combined risks of aortic valve surgery and late complications of aortic valve prosthesis need to be ...
Eligibility Criteria
Inclusion
- asymptomatic patients with very severe aortic stenosis who are potential candidates for early surgery. Very severe aortic stenosis are defined as a critical stenosis in the AV area ≤ 0.75 square centimeter fulfilling one of the following criteria; a peak aortic velocity ≥ 4.5 m/sec or a mean transaortic pressure gradient ≥ 50 mmHg on Doppler echocardiography.
- According to the revised 2014 AHA/ACC Valvular Heart Disease Guideline that recommends exercise testing to confirm the absence of symptoms in asymptomatic patients with severe AS (Class IIa), eligible patients with a positive exercise test will be excluded from the entry after May, 2014.
Exclusion
- Exertional dyspnea
- Angina
- Syncope
- Left ventricular ejection fraction \< 50%
- Significant aortic regurgitation
- Significant mitral valve disease
- Pregnancy
- Age \< 20 years or \> 80 years
- Coexisting malignancies
- Positive exercise test
Key Trial Info
Start Date :
July 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 30 2025
Estimated Enrollment :
145 Patients enrolled
Trial Details
Trial ID
NCT01161732
Start Date
July 1 2010
End Date
May 30 2025
Last Update
June 26 2025
Active Locations (4)
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1
Samsung Medical Center
Seoul, South Korea, 135-710
2
Asan Medical Center
Seoul, South Korea, 138-736
3
Seoul National University Hospital
Seoul, South Korea
4
Yonsei University Medical Center
Seoul, South Korea