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NCT Number: NCT07179302

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

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,.

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Key information

Age range

50 year–102 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Tanta University, Tanta, Gharbia Governorate, Egypt

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About this study

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.

Who can participate

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

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.

Treatment and study plan

Transcatheter Aortic Valve Implantation (TAVI)

Procedure

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.

Other names: TAVI

Primary outcomes

  1. Repeated hospitalization in one year

    Time frame: one year

    number of patients need rehospitalization

  2. Need for permanent pacemaker

    Time frame: 6 months

    number of patients need for permanent pacemaker

  3. Myocardial infarction within one year

    Time frame: one year

    incidence of MI in patients

  4. Stroke in one year

    Time frame: one year

    incidence of stroke in patients

Sponsors and collaborators

Lead sponsor

Damanhour University

Other

Collaborators

  • Tanta University
  • medina medical center

Registry information

Official study title

Comparative Evaluation of LACI and LV Speckle Tracking for Pre- and Post-TAVI Patient Assessment: Advancing Outcome Precision in Aortic Valve Therapy

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Sep 17, 2025
Registry last updated
Dec 3, 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.

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