Status:
TERMINATED
Stroke-free Survival Comparison Between Early Surgery and Conventional Therapy in Left Infective Endocarditis
Lead Sponsor:
Maria Vittoria Hospital
Collaborating Sponsors:
Ministry of Health, Italy
Conditions:
Endocarditis
Eligibility:
All Genders
18-85 years
Phase:
NA
Brief Summary
The purpose of the EARLY study is to evaluate the efficacy and effectiveness of early surgery in patients with Infective Endocarditis (IE).
Detailed Description
Infective endocarditis (IE) is a relatively rare disease and has a high in-hospital mortality (15-30%) and morbidity due to complications like embolic events, especially in the central nervous system,...
Eligibility Criteria
Inclusion
- Left-sided Infective Endocarditis (IE) according to modified Duke criteria, fulfilling at least one of the following features:
- IE on native or prosthetic valve with severe mitral or aortic valve regurgitation, without heart failure;
- IE on native or prosthetic valve, during the first week of antibiotic therapy, have very large (15-30 mm) or large (\>10mm), mobile isolated vegetations due to Staphylococcus aureus, Streptococcus bovis, HACEK or Abiotrophia, without any other indication for surgery;
- IE on native or prosthetic valve with severe valve regurgitation without heart failure and with large vegetations (\> 10 mm) and Euroscore I 5-19;
- IE on native or prosthetic valve with moderate o moderate-severe valve regurgitation with large vegetations (\> 10 mm)
- IE on prosthetic valve due to Staphylococcus aureus or gram negative non HACEK microorganisms.
- Compliance to study treatments
- Euroscore I \<20
- Informed consent signature
Exclusion
- Patients with right-side IE and IE on a cardiac device
- Patients with IE and:
- heart failure , refractory pulmonary oedema, cardiogenic shock or untreatable heart failure
- fistula involving cardiac chambers or pericardium
- persistent heart failure or unstable echocardiographic signs or poor haemodynamic tolerance
- uncontrolled local infection (abscess, pseudoaneurism, fistula, increase in size vegetations)
- fever and positive blood cultures lasting \>7 days
- fungal IE or other multi-resistant microorganisms
- large vegetations (\> 10 mm) after embolic event
- large vegetations (\> 10 mm) and other predictors of complicated course (heart failure, abscess)
- vegetations \>30 mm
Key Trial Info
Start Date :
December 22 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 14 2020
Estimated Enrollment :
6 Patients enrolled
Trial Details
Trial ID
NCT03411499
Start Date
December 22 2017
End Date
December 14 2020
Last Update
November 18 2023
Active Locations (1)
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1
SC Cardiochirurgia U - AOU Città della Salute e della Scienza di Torino - PO Molinette
Torino, Italy, 10126