Status:
UNKNOWN
Rationale, Design and Methods for the Early Surgery in Infective Endocarditis Study (ENDOVAL)
Lead Sponsor:
Instituto de Ciencias del Corazon
Conditions:
Infective Endocarditis
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
Background: Prognosis of infective endocarditis is poor and has remained steady over the last four decades. Several nonrandomized studies suggest that early surgery could improve prognosis. Methods: ...
Detailed Description
BACKGROUND Whereas mortality has been dramatically reduced in some areas of cardiac diseases thanks to continuous progress in treatment, endocarditis remains a high-mortality disease with steady perce...
Eligibility Criteria
Inclusion
- Patients older than 18 years.
- Infective endocarditis diagnosed by modified Duke criteria.
- At least one of the following risk factors:
- Periannular complications
- New onset auriculo-ventricular block
- New onset severe valvular insufficiency
- Early-onset prosthetic valve endocarditis
- Staphylococcus aureus endocarditis
- Vegetations greater than 20 mm
Exclusion
- Patients with urgent/emergent indication of surgery when endocarditis is diagnosed:
- Heart failure because of valvular insufficiency.
- Fungal endocarditis.
- Septic shock.
- Patients referred from other centers to be operated on.
- Patients without echocardiographic evidence of endocarditis.
- Pregnant or lactating women.
- Simultaneous participation in other research study.
- Incapacity to mantein the conditions of the study.
- Patients referred from other centers more than 5 days after the diagnosis of infective endocarditis.
- Patients with prohibitive risk for surgery due to comorbidities, estimated by previous validated scales. An Euroescore value greater than 40% will be considered a contraindication to enter the protocol.
- Patients with ischemic or haemorragic stroke within one month before the diagnosis of endocarditis.
- Endocarditis in intravenous drug addicts patients.
- Not signed the inform consent.
Key Trial Info
Start Date :
September 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2010
Estimated Enrollment :
216 Patients enrolled
Trial Details
Trial ID
NCT00624091
Start Date
September 1 2007
End Date
September 1 2010
Last Update
February 26 2008
Active Locations (1)
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1
Universitary Hospital of Valladolid
Valladolid, Spain, 47003