Status:
UNKNOWN
Moderate Mitral Regurgitation in CABG Patients
Lead Sponsor:
University of Aarhus
Conditions:
Moderate Mitral Regurgitation
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
Background: The presence of a mild to moderate ischemic mitral regurgitation (IMR) results in a significantly reduced long-term survival and increased hospitalizations for heart-failure. The benefit ...
Eligibility Criteria
Inclusion
- Patients with ischemic heart disease, who fulfil the indications for CABG, and who also have a moderate ischemic MR. Ischemic MR is defined as mitral regurgitation due to coronary artery disease and not fortuitously associated with it. It is caused either by a mitral annular dilatation (Carpentier type I), or a restrictive motion of the posterior mitral leaflet (Carpentier type IIIb), or a combination of these. The mitral leaflets should be slender and without signs of intrinsic organic disease. The mitral annulus should be with no significant calcification that can be held responsible for valve insufficiency. The severity of mitral regurgitation is quantified by means of echoardiography using the Proximal Isovelocity Surface Area (PISA)-method. Moderate MR is defined as a calculated ERO of 15-30 mm2 at rest . Hence, patients referred for CABG and showing signs of mitral regurgitation on auscultation, by echocardiography, or by ventriculography will further be evaluated by a thorough echocardiography (Transthoracic (TTE) in ambiguous cases supplemented by transesophageal echocardiography (TEE) before surgery, in order to determine whether the patient fulfil the inclusion criteria. In addition, ejection fraction (visually estimated), left atrial dimension, mitral annular and tricuspid annular size, as well as estimates of pulmonary hypertension will be recorded.
- Age ≥ 18 yrs.
- The inclusion is independent of the left ventricular function.
- The inclusion is independent of the left atrial size.
- It is mandatory that the patient is able to fully understand the written information, the purpose of the study, and able to give an informed consent.
Exclusion
- Patients with previous cardiac surgery.
- Emergency surgery.
- Malignant disease with an expected survival of less than 5 years.
- ST-elevation myocardial infarction within 16 days.
- Significant aortic valve disease necessitating aortic valve replacement
- Calcification of the ascending aorta.
- Significant mitral annular calcification.
- Type II MR (ruptured papillary muscle, or infracted elongated papillary muscle with prolapse)
- Refusal to participate in the study.
Key Trial Info
Start Date :
February 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2015
Estimated Enrollment :
550 Patients enrolled
Trial Details
Trial ID
NCT00613548
Start Date
February 1 2008
End Date
June 1 2015
Last Update
November 11 2008
Active Locations (1)
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1
Dep. of Cardiothoracic Surgery, Aarhus University Hospital, Skejby,
Aarhus, Denmark, 8000