Pre- and Post-TAVI Patient Assessment: Advancing Outcome Precision in Aortic Valve Therapy

Recruiting

• Conditions: Aortic Valve Stenosis

• Registration Number: NCT07179302
• Lead Sponsor: Damanhour University

Brief Summary

The aim of this study is to evaluate the combined utility of the left atrial coupling index (LACI) and left ventricular speckle tracking echocardiography (LVSTE) in improving risk stratification and outcome prediction for patients undergoing Transcatheter Aortic Valve Implantation (TAVI). This study seeks to identify novel prognostic markers that enhance the prediction of mortality, heart failure, and functional recovery, ultimately enabling more personalized clinical decision-making and optimized patient outcomes by integrating the advanced echocardiographic parameters into pre-procedural assessments,.

Detailed Description

Transcatheter Aortic Valve Implantation (TAVI) has emerged as a transformative procedure for patients with severe aortic stenosis, particularly those at high surgical risk. However, accurately predicting patient outcomes remains a significant challenge, necessitating improved risk stratification tools. This study aims to evaluate the role of the left atrial coupling index (LACI) and left ventricular speckle tracking echocardiography (LVSTE) in enhancing outcome prediction in patients undergoing TAVI.

By integrating advanced echocardiographic parameters, such as LACI, which reflects left atrial function and ventricular-atrial interaction, and LVSTE, a sensitive measure of myocardial deformation, this research seeks to uncover novel prognostic markers. A prospective cohort of TAVI patients will be studied to assess the association between these indices and post-procedural outcomes, including Repeated hospitalization, heart failure, stroke and myocardial infarction.

Study Timeline

• Study Start: 2025-05-17
• Status Verified: 2025-09
• Study First Submitted: 2025-09-10
• Study First Submitted QC: 2025-09-11
• Last Update Submitted: 2025-09-16
• Study First Posted: 2025-09-17
• Last Update Posted: 2025-09-22
• Primary Completion: 2025-09-30
• Study Completion: 2025-10-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

• Patients diagnosed with severe aortic stenosis and scheduled for TAVI.

Exclusion Criteria

• Patients with significant mitral or tricuspid valve disease requiring intervention.
• History of atrial fibrillation or other arrhythmias that preclude accurate LACI measurement.
• Poor echocardiographic window preventing reliable imaging.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Repeated hospitalization in one year	one year	number of patients need rehospitalization
Need for permanent pacemaker	3 months	number of patients need for permanent pacemaker
Myocardial infarction within one year	one year	incidence of MI in patients
Stroke in one year	one year	incidence of stroke in patients

Trial Locations

Locations (2)

Tanta University; 🇪🇬 Tanta, Gharbia Governorate, Egypt

Medina Medical Center; 🇸🇦 Madinah, Saudi Arabia