- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03718052
Early Valve Surgery Versus Conventional Treatment in Infective Endocarditis Patients With High Risk of Embolism (CHIRURGENDO)
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 (19 centers) prospective randomized open blinded end-point (PROBE) sequential superiority trial.
Study Overview
Status
Conditions
Intervention / Treatment
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 (19 centers) prospective randomized open blinded end-point (PROBE) sequential superiority trial.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Xavier DUVAL
- Phone Number: +33 140257135
- Email: xavier.duval@aphp.fr
Study Locations
-
-
-
Paris, France, 75018
- Recruiting
- Bichat Claude Bernard Hospital
-
Contact:
- Xavier Duval, MD, PhD
- Email: xaviel.duval@aphp.fr
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Early valve surgery (EVS)
Cardiac surgery as soon as possible within 72 hours of randomization
|
Early valve surgery (EVS) within 72 hours of randomization
|
Active Comparator: Conventional care
Conventional care according to the 2015 European guidelines.
|
Conventional care according to the 2015 European guidelines.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
Week 6
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Complications and deaths in patient with definite IE
Time Frame: Week 6
|
All-cause death and clinically symptomatic embolic events from randomization in patient with definite IE
|
Week 6
|
Complications and deaths
Time Frame: Months 6 and 12
|
Combination of all-cause death and clinically symptomatic embolic events documented by imaging studies up to 6 months and one-year after randomization.
|
Months 6 and 12
|
Deaths
Time Frame: Months 6 and 12
|
All-cause death up to 6 months and one-year (post study analysis) after randomization
|
Months 6 and 12
|
Symptomatic embolic events
Time Frame: Months 6 and 12
|
All clinically symptomatic embolic events documented by imaging studies up to 6 months and one-year after randomization
|
Months 6 and 12
|
Intensive care scale
Time Frame: Week 6 , Months 3, 6 and 12
|
Glasgow outcome scale and Rankin scale at week 6, month 3, 6 and one-year visits.
|
Week 6 , Months 3, 6 and 12
|
Infective EI relapse
Time Frame: Months 6 and 12
|
Relapse of infective IE up to 6 months and one-year after randomization.
|
Months 6 and 12
|
Infective EI recurrences
Time Frame: Months 6 and 12
|
Recurrences of infective IE up to 6 months and one-year after randomization.
|
Months 6 and 12
|
Rehospitalization
Time Frame: Week 6, Months 6 and 12
|
Readmission due to development of congestive heart failure up to 6 weeks, 6 months and one-year after randomization
|
Week 6, Months 6 and 12
|
Rehospitalization for valve surgery
Time Frame: Months 6 and 12
|
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
|
Months 6 and 12
|
Thrombosis and ischemia
Time Frame: Months 6 and 12
|
Six month and one-year prosthesis thrombosis, severe adverse events due to anticoagulation, ischemic stroke due to documented suboptimal anticoagulation
|
Months 6 and 12
|
Quality of life scale 1
Time Frame: Months 6 and 12
|
WhoQol scale up to 6 months and one-year after randomization.
|
Months 6 and 12
|
Quality of life scale 2
Time Frame: Months 6 and 12
|
SF36 up to 6 months and one-year after randomization.
|
Months 6 and 12
|
Delay between randomization and surgery
Time Frame: Months 12
|
Time interval between randomization and date of cardiac surgery in patients operated-on during the acute phase of the IE.
|
Months 12
|
Collaborators and Investigators
Investigators
- Principal Investigator: Xavier Duval, Bichat Hospital
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- P160952J
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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