An observational study in Left Ventricular Systolic Function, sponsored by Assiut University. Completed at 1 site in Egypt. Per ClinicalTrials.gov, last updated 2025-01-30.
Sponsored by Assiut University · Observational
Investigate the preprocedural predictors of left ventricular systolic function Recovery after TAVR
Calcific aortic stenosis (AS) is the most common valve disease in the western world requiring intervention,Although Surgical Aortic Valve Replacement (SAVR) was considered as the first therapeutic method, approximately one-third of AS patients cannot undergo SAVR due to its' high risk or contraindication.
Since Transcatheter Aortic Valve Replacement (TAVR)was performed for the first time in 2002,TAVR has emerged as a growing prevalent treatment on severe symptomatic AS with the procedure initially performed on the inoperable patients with intermediate and high risks.
Recently, the Food and Drug Administration had approved it on low-risk symptomatic subjects.
AS has to be considered a disease of the left ventricle (LV) rather than purely affecting the aortic valve, Approximately one-third of patients with severe symptomatic AS have LV systolic dysfunction .
Recovery of LV ejection fraction (LVEF) is associated with improvements in clinical outcomes after TAVR as shown by a lot of studies.
The Placement of Aortic Transcatheter Valves (PARTNER) trial demonstrated that recovery of LV function in patients with severe symptomatic AS and LV systolic dysfunction who underwent TAVR, occurs in 40% to 50% of patients .
Higher trans-aortic mean pressure gradient , less LV hypertrophy, Less LV fibrosis and absence of AF are predictors of recovery of LV function after TAVR .
However, there is still a scanty data about the predictors of LV function recovery after TAVR.
146 studies on the registry are indexed under Systolic Murmurs; 17 are open to participants now.
This study's enrollment of 75 is below the median of 200 across 53 observational studies indexed under Systolic Murmurs.
Browse Systolic Murmurs studies →Assiut University is the lead sponsor of 4,901 studies on the registry; 2,098 are open to participants now.
Of its 13 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
Counted across the registry records on this site, refreshed daily.
patients with symptomatic severe aortic stenosis eligible for TAVR with LV systolic function less than 50%
Exclusion Criteria:
patient who shows improvement of left ventricular systolic function
Diagnostic Test: Echocardiography before and after TAVR
patient who don't show improvement of left ventricular systolic function
Diagnostic Test: Echocardiography before and after TAVR
Evaluation of severity of aortic stenosis using :peak velocity ,peak and mean pressure gradient and aortic valve area by continuity equation.-Evaluation of left ventricular dimensions ,volumes and systolic function as assessed by ejection fraction (EF) by m-mode and biplane simpson's method at apical 4 and 2 chambers view Speckle tracking echocardiography(STE) Apical four-, three-, and two-chamber views were used to obtain longitudinal and circumferential strain before and follow-up after TAVR. cardiac CT :Routine full protocol before TAVR for evaluation and Detection and calculation of left ventricular fibrosis using extracellular volume. Coronary angiography:evaluate the presence of CAD and calculation of syntax score(SS)
Also known as: cardiac computed tomography and coronary angiography
left ventricular systolic function recovery by ejection fraction
absolute increase of ≥10% in EF compared with baseline
Time frame: 30 days post TAVR
left ventricular systolic function recovery by STE
Myocardial recovery by STE is defined as a ≥20% relative increase in the magnitude of global longitudinal strain compared with baseline
Time frame: 30 days post TAVR
Quality of life assessment
NIHA class .
Time frame: 30days post TAVR
Plan to share: No
This study is completed, as verified in Feb 2024. You cannot join it, but the record below documents what was studied.
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Assiut University