An interventional study of Early valve surgery (EVS) and Conventional Care in Endocarditis, sponsored by Assistance Publique - Hôpitaux de Paris. Active, not recruiting at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-05-25.
Sponsored by Assistance Publique - Hôpitaux de Paris · Not applicable, Interventional, and Prevention
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.
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.
173 studies on the registry are indexed under Endocarditis; 57 are open to participants now.
This study's enrollment of 73 is below the median of 92 across 86 interventional studies indexed under Endocarditis.
Browse Endocarditis studies →Assistance Publique - Hôpitaux de Paris is the lead sponsor of 3,592 studies on the registry; 1,033 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Length of vegetation on native aortic and/or mitral valve, as assessed by TOE * :
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cardiac surgery as soon as possible within 72 hours of randomization
Procedure: Early valve surgery (EVS)
Conventional care according to the 2015 European guidelines.
Procedure: Conventional Care
Early valve surgery (EVS) within 72 hours of randomization
Conventional care according to the 2015 European guidelines.
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.
Time frame: Week 6
Complications and deaths in patient with definite IE
All-cause death and clinically symptomatic embolic events from randomization in patient with definite IE
Time frame: 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.
Time frame: Months 6 and 12
Deaths
All-cause death up to 6 months and one-year (post study analysis) after randomization
Time frame: 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
Time frame: Months 6 and 12
Intensive care scale
Glasgow outcome scale and Rankin scale at week 6, month 3, 6 and one-year visits.
Time frame: Week 6 , Months 3, 6 and 12
Infective EI relapse
Relapse of infective IE up to 6 months and one-year after randomization.
Time frame: Months 6 and 12
Infective EI recurrences
Recurrences of infective IE up to 6 months and one-year after randomization.
Time frame: Months 6 and 12
Rehospitalization
Readmission due to development of congestive heart failure up to 6 weeks, 6 months and one-year after randomization
Time frame: 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
Time frame: 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
Time frame: Months 6 and 12
Quality of life scale 1
WhoQol scale up to 6 months and one-year after randomization.
Time frame: Months 6 and 12
Quality of life scale 2
SF36 up to 6 months and one-year after randomization.
Time frame: 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.
Time frame: Months 12
Plan to share: Undecided
No publications or documents are linked to this record.
Started Apr 2019 (actual). Primary completion is estimated for May 2025, 73 months after the start.
Of 34 interventional studies with no phase under Endocarditis, half reached primary completion within 35 months of starting (the median), counting those still running; a quarter within 22 and three quarters within 59. This study's planned 73 months is above that.
How these figures are worked out, and which studies are left out of them.
This study is active, not recruiting, as verified in May 2025. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Assistance Publique - Hôpitaux de Paris →