Early Surgery Versus Conventional Treatment in Infective Endocarditis (EASE)
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT00750373 |
Recruitment Status :
Completed
First Posted : September 10, 2008
Results First Posted : September 7, 2012
Last Update Posted : April 23, 2015
|
- Study Details
- Tabular View
- Study Results
- Disclaimer
- How to Read a Study Record
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Endocarditis | Procedure: Valve surgery with removal of vegetations | Phase 4 |
Infective Endocarditis is still associated with high mortality (16-25%) and high incidence of embolic events (10-49%), and the optimal therapeutic strategy remains unclear. The benefit of surgery was particularly high in patients with abscess formation, periannular complications, and moderate to severe heart failure related to acute mitral or aortic regurgitation. Retrospective studies reported that valve surgery was associated with improved survival, but the benefit of early surgery has not been adequately studied due to inherent treatment biases and significant differences in baseline characteristics. Embolic indications for surgery are more controversial, and surgery is usually performed in cases of recurrent emboli and persist vegetations despite appropriate antibiotic treatment. The combined risk of early surgery and valve prosthesis needs to be balanced against the potential benefit of preventing embolism and improving survival. Risk-benefit balance changes recently to favor early surgery in patients with high embolic risk of endocarditis for the following reasons. Identification of patients with high risk of embolism becomes possible with the use of transesophageal echocardiography. Patients with vegetation length > 10 mm on transesophageal echocardiography have a significantly higher risk of embolization. With advances in surgical technique, urgent surgery is feasible with low operative mortality, and the success rate of valve repair has been increased.
To the best of our knowledge, there have been no prospective outcome studies comparing early surgery with the conventional treatment strategy based on current guidelines. The purpose of this multi-center, prospective, randomized trial is to compare clinical outcomes of early surgery versus conventional treatment strategy in patients with high embolic risks of infective endocarditis.
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 76 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | A Randomized Comparison of Early Surgery Versus Conventional Treatment Strategy in Patients With High Embolic Risk of Infective Endocarditis |
Study Start Date : | September 2006 |
Actual Primary Completion Date : | April 2011 |
Actual Study Completion Date : | September 2011 |

Arm | Intervention/treatment |
---|---|
No Intervention: Conventional
Conventional Treatment based on current guidelines
|
|
Active Comparator: Surgery
Early surgery within 48 hours of randomization
|
Procedure: Valve surgery with removal of vegetations
Early valve repair or replacement with removal of vegetations within 48 hours of randomization
Other Name: early surgery |
- Number of Participants With In-hospital Death or Clinical Embolic Events [ Time Frame: within 6 weeks from the randomization ]The composite of in-hospital death and clinical embolic events confirmed by imaging studies: the acute onset of clinical symptoms or signs of embolism and the occurrences of new lesions, as confirmed by follow-up imaging studies.
- All-cause Death [ Time Frame: up to 6 month after enrollment ]
- Recurrences of Infective Endocarditis [ Time Frame: up to 6 months after enrollment ]
- All Embolic Events Including Symptomatic and Asymptomatic Embolization Documented by Imaging Studies [ Time Frame: up to 6 months after enrollment ]
- Readmission Due to Development of Congestive Heart Failure [ Time Frame: up to 6 months after enrollment ]

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 15 Years to 80 Years (Child, Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
-
Patients diagnosed as infective endocarditis based on modified Duke criteria fulfilling both conditions:
- severe mitral or aortic regurgitation
- vegetation length > 10 mm on mitral or aortic valve
Exclusion Criteria:
- Patients with urgent and emergent indication of surgery based on current guidelines; aortic abscess, moderate to severe heart failure due to valvular regurgitation, periannular complications, fungal endocarditis
- Prosthetic valve endocarditis
- Patient without vegetations on echocardiography
- Patients with ischemic or hemorrhagic stroke within 2 weeks before the admission
- Patients referred from other hospitals more than 7 days after the appropriate antibiotic treatment of infective endocarditis
- Patients who were not candidates for surgery based on age > 80 years and coexisting malignancies
- Patients who did not consent to participate

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00750373
Korea, Republic of | |
Asan Medical Center | |
Seoul, Korea, Republic of | |
Seoul National University Hospital | |
Seoul, Korea, Republic of |
Principal Investigator: | Duk-Hyun Kang, MD, PhD | Department of Medicine, Asan Medical Center, University of Ulsan College of Medicine |
Responsible Party: | Duk-Hyun Kang, Professor, Asan Medical Center |
ClinicalTrials.gov Identifier: | NCT00750373 |
Other Study ID Numbers: |
2006-0257 |
First Posted: | September 10, 2008 Key Record Dates |
Results First Posted: | September 7, 2012 |
Last Update Posted: | April 23, 2015 |
Last Verified: | April 2015 |
Endocarditis |
Endocarditis, Bacterial Endocarditis Heart Diseases Cardiovascular Diseases |
Bacterial Infections Bacterial Infections and Mycoses Infections Cardiovascular Infections |