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

NCT07179302 | Completed

• 1 other identifier: Aortic Valve Therapy
• Study Type: observational
• Target: 100
• Locations: 2 countries
• Sites: 2

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,.

Conditions

Aortic Valve Stenosis

Outcome Measures

Primary Outcomes (4)

• Repeated hospitalization in one year

  number of patients need rehospitalization

  one year

• Need for permanent pacemaker

  number of patients need for permanent pacemaker

  6 months

• Myocardial infarction within one year

  incidence of MI in patients

  one year

• Stroke in one year

  incidence of stroke in patients

  one year

Study Arms (1)

TAVI group

Patients undergoing Transcatheter Aortic Valve Implantation.

Procedure: Transcatheter Aortic Valve Implantation (TAVI)

Interventions

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.

Also known as: TAVI

TAVI group

Eligibility Criteria

• Age: 50 Years - 102 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients with severe aortic stenosis and scheduled for TAVI will be recruited from Madina Cardiac Center over a period of 12 months Data Collection * Baseline Clinical Data: Demographic information, comorbidities, and clinical risk scores * Echocardiographic Assessment: Pre procedural transthoracic echocardiography (TTE) will be performed to measure: Left Atrial Coupling Index (LACI): Left Ventricular Speckle Tracking Echocardiography (LVSTE): Global longitudinal strain (GLS) will be measured to quantify myocardial deformation. All echocardiographic measurements will be performed by experienced operators blinded to clinical outcomes.

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• medina medical center: collaborator
• Tanta University: collaborator
• Damanhour University: lead

Study Sites (2)

Tanta University

Tanta, Gharbia Governorate, 31527, Egypt

Location

Medina Medical Center

Madinah, Saudi Arabia

Location

Related Publications (2)

• Wu HW, Fortuni F, Butcher SC, van der Kley F, de Weger A, Delgado V, Jukema JW, Bax JJ, Ajmone Marsan N. Prognostic value of left ventricular myocardial work indices in patients with severe aortic stenosis undergoing transcatheter aortic valve replacement. Eur Heart J Cardiovasc Imaging. 2023 Nov 23;24(12):1682-1689. doi: 10.1093/ehjci/jead157.

  PMID: 37409583 BACKGROUND

• Takeuchi K, Yamauchi Y, Shiraki H, Sumimoto K, Shono A, Suzuki M, Yamashita K, Toba T, Kawamori H, Otake H, Hirata KI, Tanaka H. Association of acute improvement in left ventricular longitudinal function after transcatheter aortic valve implantation with outcomes for severe aortic stenosis and preserved ejection fraction. J Cardiol. 2023 Oct;82(4):234-239. doi: 10.1016/j.jjcc.2023.04.008. Epub 2023 Apr 19.

  PMID: 37085029 BACKGROUND

MeSH Terms

Conditions

Aortic Valve Stenosis

Interventions

Transcatheter Aortic Valve Replacement

Condition Hierarchy (Ancestors)

Aortic Valve Disease; Heart Valve Diseases; Heart Diseases; Cardiovascular Diseases; Ventricular Outflow Obstruction

Intervention Hierarchy (Ancestors)

Heart Valve Prosthesis Implantation; Cardiac Surgical Procedures; Cardiovascular Surgical Procedures; Surgical Procedures, Operative; Prosthesis Implantation; Thoracic Surgical Procedures

Study Officials

• Eman Elshaikh, Ass Prof.

  Madina Cardiac Center, KSA

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: September 10, 2025
• First Posted: September 17, 2025
• Study Start: February 1, 2025
• Primary Completion: October 30, 2025
• Study Completion: November 1, 2025
• Last Updated: December 3, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1); SA (1)