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

Completed

• Conditions: Left Ventricular Systolic Function
• Interventions: Diagnostic Test: Echocardiography before and after TAVR

• Registration Number: NCT05069168
• Lead Sponsor: Assiut University

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.

Study Timeline

• Study First Submitted: 2021-09-12
• Study First Submitted QC: 2021-09-25
• Study First Posted: 2021-10-06
• Study Start: 2023-12-01
• Status Verified: 2024-02
• Primary Completion: 2024-11-30
• Study Completion: 2024-12-30
• Last Update Submitted: 2025-01-28
• Last Update Posted: 2025-01-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 75

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Non LVEF recovery	Echocardiography before and after TAVR	patient who don't show improvement of left ventricular systolic function
LVEFrecovery	Echocardiography before and after TAVR	patient who shows improvement of left ventricular systolic function

Primary Outcome Measures

Name	Time	Method
left ventricular systolic function recovery by ejection fraction	30 days post TAVR	absolute increase of ≥10% in EF compared with baseline
left ventricular systolic function recovery by STE	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 Outcome Measures

Name	Time	Method
Quality of life assessment	30days post TAVR	NIHA class .

Trial Locations

Locations (1)

Medicine; 🇪🇬 Assiut, Egypt