An observational study in Aortic Valve Stenosis and Ventricular Dysfunction, Left, sponsored by Central Hospital, Nancy, France. Status unknown at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2017-12-29.
Sponsored by Central Hospital, Nancy, France · Observational
Calcified aortic stenosis is the most frequent valvulopathy in Europe and North America. Aortic stenosis is an obstacle to the ejection of blood from the left ventricle to the aorta and leads to morphological changes in the left ventricle and hemodynamic modifications.
Intrinsic ventricular performance can be characterized using three parameters:
For patients with high surgical risk (EuroSCORE II> 6), TAVI (Transcatheter Aortic Valve Implantation) is recommended for aortic valve replacement. Many complications may occur after TAVI (haemorrhagic, embolic, renal, myocardial ischemia). Post-TAVI complications may also be cardiac decompensation of the underlying cardiac disease to cardiogenic shock. However, literature on left ventricular performance after aortic valvular replacement is poor because of the difficulty and invasiveness of the analysis involved.
Cardiac energy analysis plays an additional role in understanding the clinical patients conditions. On this point, cardiac energy modifications, based on ventriculo-arterial coupling, could be indicators of cardiac function. Two methods (ultrasound and pulse contour) are used to understand and explore the ventriculo-arterial coupling, preload, postload, contractility and hemodynamic changes interactions.
Echocardiography allows the Ees / Ea and SW / PVA (Stoke work/ pressure-volume area) ratios mesurements. PRAM (Pressure Recording Analytical Method) through the MostCare® monitor, gives common hemodynamic parameters and more specific parameters such as arterial elastance (Ea) cardiac cycle efficiency (CCE), dP / dt. Cardiac cycle efficiency (CCE) is an exclusive variable that describes the hemodynamic performance in terms of energy expenditure in the patient being followed.
TAVI procedure is an acute model of ventriculo-arterial coupling modification by treatment of the ventricular ejection obstacle. The PRAM method evaluates the ventriculo-arterial coupling. The aim of our study is to evaluate by PRAM the changes in cardiac energy variables before and after aortic valve replacement by TAVI
1,025 studies on the registry are indexed under Aortic Valve Stenosis; 293 are open to participants now.
This study's planned enrollment of 20 is below the median of 200 across 435 observational studies indexed under Aortic Valve Stenosis.
Browse Aortic Valve Stenosis studies →Central Hospital, Nancy, France is the lead sponsor of 798 studies on the registry; 186 are open to participants now.
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Any patients hospitalized for TAVI
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Exclusion Criteria:
Transcatheter aortic valve implantation (TAVI) impact on cardiac energy performance
Mesurement of the cardiac cycle efficency (CCE) by PRAM method (Pressure Recording Analytical Method)
Time frame: Change from baseline CCE at 30 minutes after transcatheter aortic valve implantation
Echocardiographic cardiac energy performance modification after transcatheter aortic valve implantation
Echocardiography explorations (end diastolic diameter, end systolic diameter, diastolic wall thickness, systolic wall thickness, end diastolic volume, end systolic volume, percent fractional shortening, percent ejection fraction)
Time frame: Change from baseline at 24 hours after transcatheter aortic valve implantation
Myocardial ischemia risk
Buffington index (calculated as : mean arterial pressure / heart rate)
Time frame: Change from baseline at 24 hours after transcatheter aortic valve implantation
Myocardial ischemia
Serum troponin level
Time frame: Change from baseline at 24 hours after transcatheter aortic valve implantation
This study is status unknown, as verified in Sep 2017. You cannot join it, but the record below documents what was studied.
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