Antibiotics vs antibiotics and Surgical ThERapy for Infective endocarditis

Recruiting

Conditions: endocarditis
infection of the heart valve
10046973
10004018
10007593

Registration Number: NL-OMON53957

Lead Sponsor: niversity Hospital of Copenhagen, Rigshospitalet

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

Target Recruitment: 30

Inclusion Criteria

• Definite left-sided infective endocarditis
AND
• Valve vegetation =>10 mm AND <=30 mm with 1 or no previous embolic event
during current infective endocarditis case

Exclusion Criteria

• Unwilling to sign informed consent
• At least one clear class I recommendation for surgery because of heart
failure or uncontrolled local infection (abscess, false aneurysm, fistula)
• Unavailable for follow-up (e.g. tourist)
OR
At least one of the following criteria (unsuitable for surgery):
• Intracranial hemorrhage <1 month
• Life expectancy <1 year
• Age >=85 years
• BMI below 15 or above 45
• Possible severe liver cirrhosis (Child-Pugh Class B or worse)
• Clinical frailty score of 6 or above
• EUROSCORE II >50%
• Severe pulmonary disease (FEV1 or DLCO <30% of expected)
• Left ventricular ejection fraction <20%
• Technically inoperable (e.g. extracorporeal circulation deemed impossible)

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>A composite of one of the following criteria:<br /><br>1. Death<br /><br>2. New clinical stroke with persisting symptoms >24 hours from onset<br /><br>3. New systemic embolization with clinical symptoms (e.g. clinical recognizable<br /><br>embolization by symptoms to brain, kidney, spleen, eyes, or extremities)<br /><br>4. New endocarditis event (both relapse (relapse of bacteria with the same<br /><br>organism >7 days after study intervention, vegetation enlargement (>50%) or<br /><br>local spreading of the vegetation) and reinfection (new endocarditis episode<br /><br>after completed treatment for the initial endocarditis episode))<br /><br>5. Unplanned hospitalization for new heart failure</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>1. Individual components of the primary endpoint at study conclusion<br /><br>2. Unplanned heart valve surgery due to infective endocarditis<br /><br>3. End stage renal replacement therapy in a patient without this at<br /><br>randomization<br /><br>4. Pacemaker or pacemaker extraction<br /><br>5. Cause-specific mortality (cardiovascular and non-cardiovascular (infectious,<br /><br>malignancy, other, and unknown)<br /><br>6. Days in hospital,<br /><br>7. Clinical status at discharge (need for help with daily activities, use of<br /><br>utilities for walking, home help, discharged to nursing facility, or disability<br /><br>pension)</p><br>