EndocarditisCHIRURGENDONCT03718052
Early Valve Surgery Versus Conventional Treatment in Infective Endocarditis Patients With High Risk of Embolism
A study testing Early valve surgery (EVS) and Conventional Care in people with Endocarditis, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Endocarditis
- What is being tested?
- Early valve surgery (EVS) and Conventional Care
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 73 participants
- Where
- 1 siteFrance
- Study dates
- 11 Apr 2019to 31 Jul 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
- Initiation of specific IE active antibiotic less than 5 days (≤120 hours) before inclusion
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Early Valve Surgery Versus Conventional Treatment in Infective Endocarditis Patients With High Risk of Embolism: a Randomized Superiority Clinical Trial
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.
Read the detailed description
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. Indications of valve surgery for prevention of embolic complications are less clearly defined. Potential complications of valve surgery and of implanted permanent prosthetic valve are to be balanced against their potential benefits in terms of prevented embolism and improved survival. 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 points in favor of early valve surgery (EVS) in patients with high embolic risk include the following 1) patients with high risk of embolism are identified by transesophageal echocardiography (TOE); 2) advances in surgical management of IE dramatically lowered postoperative mortality; 3) 2015 European ESC IE guidelines state that valve surgery should be performed in IE with vegetation above 10 mm AND an embolic event occurring while patients are receiving antibiotic (grade I/B) and should be considered in IE with vegetation above 30 mm (Grade IIaB ) and may be above 10 mm and severe valve regurgitation.
The primary objective is to compare clinical outcomes of EVS (as soon as possible within 72 hours of randomization) with those of a conventional management based on current 2015 European ESC guidelines in patients with native left-sided IE and high risk of embolism.
The primary assessment criterion is a composite of all-cause death and clinically symptomatic embolic events within 6 weeks from randomization in all included patient.
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
- Being tested
- Early valve surgery (EVS), Conventional Care
- Medical subject headings
- Endocarditis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Early valve surgery (EVS)Procedure or surgery
Early valve surgery (EVS) within 72 hours of randomization
Conventional CareProcedure or surgery
Conventional care according to the 2015 European guidelines.
| Study group | Role | What they receive |
|---|---|---|
| Early valve surgery (EVS) | Experimental | Cardiac surgery as soon as possible within 72 hours of randomization Receives: Procedure: Early valve surgery (EVS) |
| Conventional care | Active comparator | Conventional care according to the 2015 European guidelines. Receives: Procedure: Conventional Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Week 6
Secondary outcomes (13)
Complications and deaths in patient with definite IE
All-cause death and clinically symptomatic embolic events from randomization in patient with definite IE
Measured: Week 6
Complications and deaths
Combination of all-cause death and clinically symptomatic embolic events documented by imaging studies up to 6 months and one-year after randomization.
Measured: Months 6 and 12
Deaths
All-cause death up to 6 months and one-year (post study analysis) after randomization
Measured: Months 6 and 12
Symptomatic embolic events
All clinically symptomatic embolic events documented by imaging studies up to 6 months and one-year after randomization
Measured: Months 6 and 12
Intensive care scale
Glasgow outcome scale and Rankin scale at week 6, month 3, 6 and one-year visits.
Measured: Week 6 , Months 3, 6 and 12
Infective EI relapse
Relapse of infective IE up to 6 months and one-year after randomization.
Measured: Months 6 and 12
Infective EI recurrences
Recurrences of infective IE up to 6 months and one-year after randomization.
Measured: Months 6 and 12
Rehospitalization
Readmission due to development of congestive heart failure up to 6 weeks, 6 months and one-year after randomization
Measured: Week 6, Months 6 and 12
Rehospitalization for valve surgery
Readmission for valve surgery (between hospital discharge and 6 months and one-year after enrolment) in patients operated on during the acute phase of IE
Measured: Months 6 and 12
Thrombosis and ischemia
Six month and one-year prosthesis thrombosis, severe adverse events due to anticoagulation, ischemic stroke due to documented suboptimal anticoagulation
Measured: Months 6 and 12
Quality of life scale 1
WhoQol scale up to 6 months and one-year after randomization.
Measured: Months 6 and 12
Quality of life scale 2
SF36 up to 6 months and one-year after randomization.
Measured: Months 6 and 12
Delay between randomization and surgery
Time interval between randomization and date of cardiac surgery in patients operated-on during the acute phase of the IE.
Measured: Months 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Oct 2018
- Study start11 Apr 2019
- Primary completion31 May 2025 (estimated)
- Study completion31 Jul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EndocarditisStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 73 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Xavier Duval, Principal investigator, Bichat Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03718052
- Sponsor's protocol ID
- P160952J
- Acronym
- CHIRURGENDO
- Status last verified
- May 2025
- First submitted
- 10 Oct 2018
- Last updated
- 25 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 25 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Valve Surgery Versus Conventional Treatment in Infective Endocarditis Patients With High Risk of Embolism: a Randomized Superiority Clinical Trial
- ClinicalTrials.gov ID
- NCT03718052
- Acronym / sponsor ID
- CHIRURGENDO / P160952J
- Conditions
- Endocarditis
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 73 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- 11 Apr 2019 (actual)
- Primary completion
- 31 May 2025 (estimated)
- Study completion
- 31 Jul 2026 (estimated)
- First posted
- 24 Oct 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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. Indications of valve surgery for prevention of embolic complications are less clearly defined. Potential complications of valve surgery and of implanted permanent prosthetic valve are to be balanced against their potential benefits in terms of prevented embolism and improved survival. 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 points in favor of early valve surgery (EVS) in patients with high embolic risk include the following 1) patients with high risk of embolism are identified by transesophageal echocardiography (TOE); 2) advances in surgical management of IE dramatically lowered postoperative mortality; 3) 2015 European ESC IE guidelines state that valve surgery should be performed in IE with vegetation above 10 mm AND an embolic event occurring while patients are receiving antibiotic (grade I/B) and should be considered in IE with vegetation above 30 mm (Grade IIaB ) and may be above 10 mm and severe valve regurgitation.
The primary objective is to compare clinical outcomes of EVS (as soon as possible within 72 hours of randomization) with those of a conventional management based on current 2015 European ESC guidelines in patients with native left-sided IE and high risk of embolism.
The primary assessment criterion is a composite of all-cause death and clinically symptomatic embolic events within 6 weeks from randomization in all included patient.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Early valve surgery (EVS) | Experimental | Procedure: Early valve surgery (EVS)Cardiac surgery as soon as possible within 72 hours of randomization |
| Conventional care | Active comparator | Procedure: Conventional CareConventional care according to the 2015 European guidelines. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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 * :
- Initiation of specific IE active antibiotic less than 5 days (≤120 hours) before inclusion
- 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.
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Early valve surgery (EVS)Early valve surgery (EVS) within 72 hours of randomization | Procedure or surgery | Early valve surgery (EVS) |
| Conventional CareConventional care according to the 2015 European guidelines. | Procedure or surgery | Conventional care |
Primary outcome
Complications and deaths in all included patient
Time frame: Week 6
A composite of all-cause death and clinically symptomatic embolic events within 6 weeks from randomization in all included patient.
13 secondary outcomes
Complications and deaths in patient with definite IE
Time frame: Week 6
Complications and deaths
Time frame: Months 6 and 12
Deaths
Time frame: Months 6 and 12
Symptomatic embolic events
Time frame: Months 6 and 12
Intensive care scale
Time frame: Week 6 , Months 3, 6 and 12
Infective EI relapse
Time frame: Months 6 and 12
Infective EI recurrences
Time frame: Months 6 and 12
Rehospitalization
Time frame: Week 6, Months 6 and 12
Rehospitalization for valve surgery
Time frame: Months 6 and 12
Thrombosis and ischemia
Time frame: Months 6 and 12
Quality of life scale 1
Time frame: Months 6 and 12
Quality of life scale 2
Time frame: Months 6 and 12
Delay between randomization and surgery
Time frame: Months 12
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 May 2025.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Xavier Duval principal investigator
Bichat Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Early valve surgery (EVS) and Conventional Care in people with Endocarditis, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 25 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Complications and deaths in all included patient (time frame: Week 6). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 May 2025.