Status:
NOT_YET_RECRUITING
Hemodynamic Evaluation of Left Atrial Pressure in Relationship to Pulmonary Capillary Wedge Pressure in Cardio Thoracic Patients
Lead Sponsor:
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Conditions:
Cardiogenic Shock
Pulmonary Edema Cardiac Cause
Eligibility:
All Genders
18+ years
Brief Summary
Accurate hemodynamic monitoring is critical in cardiothoracic surgery, where left atrial pressure (LAP) serves as the gold standard for assessing left-sided cardiac filling pressures. However, its inv...
Detailed Description
Effective hemodynamic monitoring is essential for optimizing postoperative management in cardiothoracic surgery. Left atrial pressure (LAP) is considered the gold standard for assessing left-sided car...
Eligibility Criteria
Inclusion
- the primary procedure is cardiac surgery by median sternotomy
- the use of CPB
- patients undergoing aortic valve replacement (AVR) due to aortic regurgitation, mitral valve plasty (MVP), mitral valve repair (MVR), valve sparing aortic root replacement or supracoronary aorta ascendens replacement (SCAR)
- left ventricular ejection fraction of 60% or more
- no clinical or echocardiographic signs of preoperative decompensation cordis
- only elective procedures
Exclusion
- patients with left ventricular hypertrophy (LVH), severe aortic stenosis or hypertrophic obstructive cardiomyopathy. LVH is defined as an increased LVMI greater than 95 grams per square meter (g/m²) in women and greater than 115 g/m² in men.
- patients with echocardiographically observed RV or LV dilatation are assessed using specific criteria. For RV dilatation, a TAPSE of less than 14 millimeters or an RV FAC of less than 35% is indicative of dilatation. For LV dilatation, an LV end-diastolic (LVED) diameter greater than 2.7 centimeters per square meter or exceeding 117% of the predicted value, adjusted for age and body surface area, is considered dilated.
- patients undergoing more than one type of procedure (i.e. double valve surgery, CABG and AVR)
- postoperative aortic valve mean pressure gradient of more than 20 mm Hg and mitral valve mean pressure gradient of more than 5 mm Hg
- postoperative paravalvular leak grade 2 or more
- postoperative persistent regional wall abnormalities or electrocardiographic signs of acute ischemia
- other significant valve pathology, such as moderate mitral regurgitation
Key Trial Info
Start Date :
September 1 2025
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
October 1 2026
Estimated Enrollment :
136 Patients enrolled
Trial Details
Trial ID
NCT07163052
Start Date
September 1 2025
End Date
October 1 2026
Last Update
September 9 2025
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