Aortic Valve StenosisNCT07179302
Pre- and Post-TAVI Patient Assessment: Advancing Outcome Precision in Aortic Valve Therapy
An observational study of Aortic Valve Stenosis, run by Damanhour University at 2 sites in 2 countries.
Trial 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). Read more about this study
- Who is it for?
- Ages 50 to 102 years
- Conditions the study is for
- Aortic Valve Stenosis
- What is being tested?
- Transcatheter Aortic Valve Implantation (TAVI)
- Type of treatment
- Surgery or procedure
- How many people
- 100 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 1 Feb 2025to 1 Nov 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 102 years
- All sexes
- Adult, Older adult
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.
Who may be able to join
- Patients diagnosed with severe aortic stenosis and scheduled for TAVI.
Who cannot join
- 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.
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
About this study
Official title: Comparative Evaluation of LACI and LV Speckle Tracking for 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,.
Read the 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.
- Conditions
- Aortic Valve Stenosis
- Being tested
- Transcatheter Aortic Valve Implantation (TAVI)
- Medical subject headings
- Aortic Valve Stenosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcatheter Aortic Valve Implantation (TAVI)Procedure or surgery
Also called 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.
| Study group | Role | What they receive |
|---|---|---|
| TAVI group | Patients undergoing Transcatheter Aortic Valve Implantation. Receives: Procedure: Transcatheter Aortic Valve Implantation (TAVI) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Repeated hospitalization in one year
number of patients need rehospitalization
Measured: one year
Need for permanent pacemaker
number of patients need for permanent pacemaker
Measured: 6 months
Myocardial infarction within one year
incidence of MI in patients
Measured: one year
Stroke in one year
incidence of stroke in patients
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Sep 2025
- Study start1 Feb 2025
- Primary completion30 Oct 2025
- Study completion1 Nov 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Aortic Valve StenosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Damanhour University
- Sponsor type
- University, hospital or other
- Collaborators
- medina medical center, Tanta University
- Responsible party
- Principal investigator, Rehab Werida, Damanhour University
- Investigators
- Eman Elshaikh, Ass Prof., Study chair, Madina Cardiac Center, KSA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07179302
- Sponsor's protocol ID
- Aortic Valve Therapy
- Status last verified
- Nov 2025
- First submitted
- 10 Sep 2025
- Last updated
- 3 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 37409583Takeuchi 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.
PubMed 37085029
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Evaluation of LACI and LV Speckle Tracking for Pre- and Post-TAVI Patient Assessment: Advancing Outcome Precision in Aortic Valve Therapy
- ClinicalTrials.gov ID
- NCT07179302
- Acronym / sponsor ID
- Aortic Valve Therapy
- Conditions
- Aortic Valve Stenosis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Damanhour UniversityUniversity, hospital or other
- Collaborators
- medina medical center, Tanta University
- Study start
- 1 Feb 2025 (actual)
- Primary completion
- 30 Oct 2025 (actual)
- Study completion
- 1 Nov 2025 (actual)
- First posted
- 17 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| TAVI group | – | Procedure: Transcatheter Aortic Valve Implantation (TAVI)Patients undergoing Transcatheter Aortic Valve Implantation. |
Who may qualify
- Ages
- 50 to 102 years
- Sex
- All
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- Patients diagnosed with severe aortic stenosis and scheduled for TAVI.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Transcatheter Aortic Valve Implantation (TAVI)Also: TAVIevaluate the role of the left atrial coupling index (LACI) and left ventricular speckle tracking echocardiography (LVSTE) in enhancing outcome prediction in patients undergoing TAVI. | Procedure or surgery | TAVI group |
Primary outcome
Repeated hospitalization in one year
Time frame: one year
number of patients need rehospitalization
Need for permanent pacemaker
Time frame: 6 months
number of patients need for permanent pacemaker
Myocardial infarction within one year
Time frame: one year
incidence of MI in patients
Stroke in one year
Time frame: one year
incidence of stroke in patients
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Dec 2025.
- Background: PubMed 37409583Wu 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.
- Background: PubMed 37085029Takeuchi 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Eman Elshaikh, Ass Prof. study chair
Madina Cardiac Center, KSA
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Aortic Valve Stenosis, run by Damanhour University at 2 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Egypt, Saudi Arabia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Repeated hospitalization in one year (time frame: one year). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07179302, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Dec 2025.