Status:
COMPLETED
Early Surgery Versus Conventional Treatment in Infective Endocarditis
Lead Sponsor:
Asan Medical Center
Conditions:
Endocarditis
Eligibility:
All Genders
15-80 years
Phase:
PHASE4
Brief Summary
There have been no prospective clinical studies in infective endocarditis comparing early surgery with the conventional treatment strategy based on current guidelines. The purpose of this prospective ...
Detailed Description
Infective Endocarditis is still associated with high mortality (16-25%) and high incidence of embolic events (10-49%), and the optimal therapeutic strategy remains unclear. The benefit of surgery was ...
Eligibility Criteria
Inclusion
- Patients diagnosed as infective endocarditis based on modified Duke criteria fulfilling both conditions:
- severe mitral or aortic regurgitation
- vegetation length \> 10 mm on mitral or aortic valve
Exclusion
- Patients with urgent and emergent indication of surgery based on current guidelines; aortic abscess, moderate to severe heart failure due to valvular regurgitation, periannular complications, fungal endocarditis
- Prosthetic valve endocarditis
- Patient without vegetations on echocardiography
- Patients with ischemic or hemorrhagic stroke within 2 weeks before the admission
- Patients referred from other hospitals more than 7 days after the appropriate antibiotic treatment of infective endocarditis
- Patients who were not candidates for surgery based on age \> 80 years and coexisting malignancies
- Patients who did not consent to participate
Key Trial Info
Start Date :
September 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2011
Estimated Enrollment :
76 Patients enrolled
Trial Details
Trial ID
NCT00750373
Start Date
September 1 2006
End Date
September 1 2011
Last Update
April 23 2015
Active Locations (2)
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1
Asan Medical Center
Seoul, South Korea
2
Seoul National University Hospital
Seoul, South Korea