Early valve surgery (EVS): Early valve surgery (EVS) within 72 hours of randomization
Conventional Care: Conventional care according to the 2015 European guidelines.
Study summary
Infective endocarditis (IE) is associated with an overall in-hospital mortality rate of 15-25% and a high incidence of embolic events (20-50%). Leading causes of mortality are heart failure (HF) resulting from valve dysfunction, and stroke caused by vegetation embolization. The rate of symptomatic embolic events occurring after antibiotic initiation is around 15%. Valve surgery benefit has been clearly demonstrated in patients with periannular complications and moderate to severe HF resulting from acute valve regurgitation. The timing of surgery to prevent embolism is critical since the risk of new embolic event is highest during the first weeks of antibiotic treatment.
The primary objective is to compare clinical outcomes of Early Valve Surgery (as soon as possible within 72 hours of randomization) with those of a conventional management based on current guidelines in patients with native left-sided IE and high risk of embolism.
208 patients (104 patients per arm) will be included in a national multicenter (21 centers) prospective randomized open blinded end-point (PROBE) sequential superiority trial.
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria:
1. Age ≥ 18 years
2. Definite or possible IE based on the modified Duke criteria (ESC 2015)
3. Length of vegetation on native aortic and/or mitral valve, as assessed by TOE \* :
* between 10 and 15 mm AND (severe regurgitation OR previous symptomatic or asymptomatic embolic events)
* OR above or equal to 15 mm
4. Initiation of specific IE active antibiotic less than 5 days (≤120 hours) before inclusion
5. For non-menopause women: negative blood or urinary β-HCG test. \*If the patient has several vegetations, only one vegetation with these criterions, is enough to included patient.
Exclusion Criteria:
1. Patient with "emergent" indication of surgery based on 2015 European Guidelines
2. Prosthetic valve endocarditis
3. Patient who is not candidate for surgery due to high risk post-surgery mortality including for example coexisting major embolic stroke with a high risk of hemorrhagic transformation, symptomatic hemorrhagic stroke; poor medical status, such as coexisting malignancies…
4. No written informed consent from the patient or a legal representative if appropriate
5. Patient with no national health or universal plan affiliation coverage
6. Pregnancy
7. Patient under guardianship or curatorship
Primary outcome measure(s)
Complications and deaths in all included patient — Week 6 A composite of all-cause death and clinically symptomatic embolic events within 6 weeks from randomization in all included patient.
Trial sites (1)
Facility
City
Region
Status
Bichat Claude Bernard Hospital
Paris
France
More Assistance Publique - Hôpitaux de Paris trials in France
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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