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Completed

NCT Number: NCT05069168

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

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

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Key information

Sex eligibility

All sexes

Study type

Observational

Primary location

Medicine

Asyut, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Echocardiography before and after TAVR

Diagnostic Test

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)

Other names: cardiac computed tomography and coronary angiography

Primary outcomes

  1. left ventricular systolic function recovery by ejection fraction

    Time frame: 30 days post TAVR

    absolute increase of ≥10% in EF compared with baseline

  2. 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

  1. Quality of life assessment

    Time frame: 30days post TAVR

    NIHA class .

Sponsors and collaborators

Lead sponsor

Assiut University

Other

Registry information

Official study title

Predictors of Left Ventricular Systolic Function Recovery After Transcatheter Aortic Valve

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Oct 6, 2021
Registry last updated
Jan 30, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.