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

NCT ID: NCT07179302

Last Updated: 2025-12-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-02-01

Study Completion Date

2025-11-01

Brief Summary

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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

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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.

Conditions

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Aortic Valve Stenosis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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TAVI group

Patients undergoing Transcatheter Aortic Valve Implantation.

Transcatheter Aortic Valve Implantation (TAVI)

Intervention Type 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.

Interventions

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Transcatheter Aortic Valve Implantation (TAVI)

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.

Intervention Type PROCEDURE

Other Intervention Names

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TAVI

Eligibility Criteria

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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.
Minimum Eligible Age

50 Years

Maximum Eligible Age

102 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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medina medical center

OTHER

Sponsor Role collaborator

Tanta University

OTHER

Sponsor Role collaborator

Damanhour University

OTHER

Sponsor Role lead

Responsible Party

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Rehab Werida

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Eman Elshaikh, Ass Prof.

Role: STUDY_CHAIR

Madina Cardiac Center, KSA

Locations

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Tanta University

Tanta, Gharbia Governorate, Egypt

Site Status

Medina Medical Center

Madinah, , Saudi Arabia

Site Status

Countries

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Egypt Saudi Arabia

References

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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.

Reference Type BACKGROUND
PMID: 37409583 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 37085029 (View on PubMed)

Other Identifiers

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Aortic Valve Therapy

Identifier Type: -

Identifier Source: org_study_id

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