Phase 4
Completed N=76
Early Surgery Versus Conventional Treatment in Infective Endocarditis
Endocarditis
Source: ClinicalTrials.gov NCT00750373 ↗
Enrolled (actual)
76
Serious AEs
13.2%
Results posted
Sep 2012
Primary outcomePrimary: Number of Participants With In-hospital Death or Clinical Embolic Events — 9; 1 participants — p=<0.05
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 randomized trial is to compare clinical outcomes of early surgery versus conventional treatment strategy in patients with high embolic risk of infective endocarditis.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With In-hospital Death or Clinical Embolic Events |
9; 1 | <0.05 sig |
| SECONDARY All-cause Death |
— | — |
| SECONDARY Recurrences of Infective Endocarditis |
— | — |
| SECONDARY All Embolic Events Including Symptomatic and Asymptomatic Embolization Documented by Imaging Studies |
— | — |
| SECONDARY Readmission Due to Development of Congestive Heart Failure |
— | — |
Eligibility Criteria
Inclusion Criteria
- 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 Criteria
- 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
Data sourced from ClinicalTrials.gov (NCT00750373). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.