Early Valve Surgery Versus Conventional Treatment in Infective Endocarditis Patients With High Risk of Embolism

NCT03718052 | Active Not Recruiting

• 1 other identifier: P160952J
• Study Type: interventional
• Target: 73
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Endocarditis

Outcome Measures

Primary Outcomes (1)

• Complications and deaths in all included patient

  A composite of all-cause death and clinically symptomatic embolic events within 6 weeks from randomization in all included patient.

  Week 6

Secondary Outcomes (13)

• Complications and deaths in patient with definite IE

  Week 6

• Complications and deaths

  Months 6 and 12

• Deaths

  Months 6 and 12

• Symptomatic embolic events

  Months 6 and 12

• Intensive care scale

  Week 6 , Months 3, 6 and 12

Study Arms (2)

Early valve surgery (EVS)

EXPERIMENTAL

Cardiac surgery as soon as possible within 72 hours of randomization

Procedure: Early valve surgery (EVS)

Conventional care

ACTIVE COMPARATOR

Conventional care according to the 2015 European guidelines.

Procedure: Conventional Care

Interventions

Early valve surgery (EVS) PROCEDURE

Early valve surgery (EVS) within 72 hours of randomization

Early valve surgery (EVS)

Conventional Care PROCEDURE

Conventional care according to the 2015 European guidelines.

Conventional care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥ 18 years
• Definite or possible IE based on the modified Duke criteria (ESC 2015)
• 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
• 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.

You may not qualify if:

• Patient with "emergent" indication of surgery based on 2015 European Guidelines
• Prosthetic valve endocarditis
• 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…
• No written informed consent from the patient or a legal representative if appropriate
• Patient with no national health or universal plan affiliation coverage
• Pregnancy
• Patient under guardianship or curatorship

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

Study Sites (1)

Bichat Claude Bernard Hospital

Paris, 75018, France

Location

MeSH Terms

Conditions

Endocarditis

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Officials

• Xavier Duval

  Bichat Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 10, 2018
• First Posted: October 24, 2018
• Study Start: April 11, 2019
• Primary Completion: May 31, 2025
• Study Completion (Estimated): July 31, 2026
• Last Updated: May 25, 2025

Record last verified: 2025-05

Locations

FR (1)