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Clinical Trials/NCT05069168
NCT05069168
Completed
N/A

Predictors of Left Ventricular Systolic Function Recovery After Transcatheter Aortic Valve

Assiut University1 site in 1 country75 target enrollmentDecember 1, 2023

Overview

Phase
N/A
Intervention
Not specified
Conditions
Left Ventricular Systolic Function
Sponsor
Assiut University
Enrollment
75
Locations
1
Primary Endpoint
left ventricular systolic function recovery by ejection fraction
Status
Completed
Last Updated
last year

Overview

Brief Summary

Investigate the preprocedural predictors of left ventricular systolic function Recovery after TAVR

Detailed Description

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.

Registry
clinicaltrials.gov
Start Date
December 1, 2023
End Date
December 30, 2024
Last Updated
last year
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Anwar S Helen

Principle investigator

Assiut University

Eligibility Criteria

Inclusion Criteria

  • patients with symptomatic severe aortic stenosis eligible for TAVR with LV systolic function less than 50%.

Exclusion Criteria

  • Severe Rheumatic or degenerative mitral regurgitation.
  • Previous Valve Replacement.
  • Previous myocardial infarction.
  • Previous Coronary Artery By Bass Graft (CABG)Surgery.
  • Post TAVR significant paravalvular leakage

Outcomes

Primary Outcomes

left ventricular systolic function recovery by ejection fraction

Time Frame: 30 days post TAVR

absolute increase of ≥10% in EF compared with baseline

left ventricular systolic function recovery by STE

Time Frame: 30 days post TAVR

Myocardial recovery by STE is defined as a ≥20% relative increase in the magnitude of global longitudinal strain compared with baseline

Secondary Outcomes

  • Quality of life assessment(30days post TAVR)

Study Sites (1)

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