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Predictors of Left Ventricular Systolic Function Recovery After Transcatheter Aortic Valve Replacement

A

Assiut University

Status

Completed

Conditions

Left Ventricular Systolic Function

Treatments

Diagnostic Test: Echocardiography before and after TAVR

Study type

Observational

Funder types

Other

Identifiers

Details and patient eligibility

About

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

Full 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.

Enrollment

75 patients

Sex

All

Volunteers

No Healthy Volunteers

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

Trial design

75 participants in 2 patient groups

LVEFrecovery
Description:
patient who shows improvement of left ventricular systolic function
Treatment:
Diagnostic Test: Echocardiography before and after TAVR
Non LVEF recovery
Description:
patient who don't show improvement of left ventricular systolic function
Treatment:
Diagnostic Test: Echocardiography before and after TAVR

Trial contacts and locations

1

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Central trial contact

Helen sami Anwar; Mohamed k fargal Abdelmegid

Data sourced from clinicaltrials.gov

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