Predictors of Left Ventricular Systolic Function Recovery After Transcatheter Aortic Valve Replacement

NCT ID: NCT05069168

Last Updated: 2025-01-30

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

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

75 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-12-01

Study Completion Date

2024-12-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

Investigate the preprocedural predictors of left ventricular systolic function Recovery after TAVR

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Calcific aortic stenosis (AS) is the most common valve disease in the western world requiring intervention,Although Surgical Aortic Valve Replacement (SAVR) was considered as the first therapeutic method, approximately one-third of AS patients cannot undergo SAVR due to its' high risk or contraindication.

Since Transcatheter Aortic Valve Replacement (TAVR)was performed for the first time in 2002,TAVR has emerged as a growing prevalent treatment on severe symptomatic AS with the procedure initially performed on the inoperable patients with intermediate and high risks.

Recently, the Food and Drug Administration had approved it on low-risk symptomatic subjects.

AS has to be considered a disease of the left ventricle (LV) rather than purely affecting the aortic valve, Approximately one-third of patients with severe symptomatic AS have LV systolic dysfunction .

Recovery of LV ejection fraction (LVEF) is associated with improvements in clinical outcomes after TAVR as shown by a lot of studies.

The Placement of Aortic Transcatheter Valves (PARTNER) trial demonstrated that recovery of LV function in patients with severe symptomatic AS and LV systolic dysfunction who underwent TAVR, occurs in 40% to 50% of patients .

Higher trans-aortic mean pressure gradient , less LV hypertrophy, Less LV fibrosis and absence of AF are predictors of recovery of LV function after TAVR .

However, there is still a scanty data about the predictors of LV function recovery after TAVR.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Left Ventricular Systolic Function

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

CASE_ONLY

Study Time Perspective

RETROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

LVEFrecovery

patient who shows improvement of left ventricular systolic function

Echocardiography before and after TAVR

Intervention Type DIAGNOSTIC_TEST

Evaluation of severity of aortic stenosis using :peak velocity ,peak and mean pressure gradient and aortic valve area by continuity equation.-Evaluation of left ventricular dimensions ,volumes and systolic function as assessed by ejection fraction (EF) by m-mode and biplane simpson's method at apical 4 and 2 chambers view Speckle tracking echocardiography(STE) Apical four-, three-, and two-chamber views were used to obtain longitudinal and circumferential strain before and follow-up after TAVR.

cardiac CT :Routine full protocol before TAVR for evaluation and Detection and calculation of left ventricular fibrosis using extracellular volume.

Coronary angiography:evaluate the presence of CAD and calculation of syntax score(SS)

Non LVEF recovery

patient who don't show improvement of left ventricular systolic function

Echocardiography before and after TAVR

Intervention Type DIAGNOSTIC_TEST

Evaluation of severity of aortic stenosis using :peak velocity ,peak and mean pressure gradient and aortic valve area by continuity equation.-Evaluation of left ventricular dimensions ,volumes and systolic function as assessed by ejection fraction (EF) by m-mode and biplane simpson's method at apical 4 and 2 chambers view Speckle tracking echocardiography(STE) Apical four-, three-, and two-chamber views were used to obtain longitudinal and circumferential strain before and follow-up after TAVR.

cardiac CT :Routine full protocol before TAVR for evaluation and Detection and calculation of left ventricular fibrosis using extracellular volume.

Coronary angiography:evaluate the presence of CAD and calculation of syntax score(SS)

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Echocardiography before and after TAVR

Evaluation of severity of aortic stenosis using :peak velocity ,peak and mean pressure gradient and aortic valve area by continuity equation.-Evaluation of left ventricular dimensions ,volumes and systolic function as assessed by ejection fraction (EF) by m-mode and biplane simpson's method at apical 4 and 2 chambers view Speckle tracking echocardiography(STE) Apical four-, three-, and two-chamber views were used to obtain longitudinal and circumferential strain before and follow-up after TAVR.

cardiac CT :Routine full protocol before TAVR for evaluation and Detection and calculation of left ventricular fibrosis using extracellular volume.

Coronary angiography:evaluate the presence of CAD and calculation of syntax score(SS)

Intervention Type DIAGNOSTIC_TEST

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

cardiac computed tomography and coronary angiography

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* patients with symptomatic severe aortic stenosis eligible for TAVR with LV systolic function less than 50%.

Exclusion Criteria

* Severe Rheumatic or degenerative mitral regurgitation.
* Previous Valve Replacement.
* Previous myocardial infarction.
* Previous Coronary Artery By Bass Graft (CABG)Surgery.
* Post TAVR significant paravalvular leakage
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Assiut University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Anwar S Helen

Principle investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Hatem A Helmy

Role: STUDY_DIRECTOR

Assiut University

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Medicine

Asyut, , Egypt

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Egypt

References

Explore related publications, articles, or registry entries linked to this study.

Passeri JJ, Elmariah S, Xu K, Inglessis I, Baker JN, Alu M, Kodali S, Leon MB, Svensson LG, Pibarot P, Fearon WF, Kirtane AJ, Vlahakes GJ, Palacios IF, Douglas PS; PARTNER Investigators. Transcatheter aortic valve replacement and standard therapy in inoperable patients with aortic stenosis and low EF. Heart. 2015 Mar;101(6):463-71. doi: 10.1136/heartjnl-2014-306737. Epub 2015 Jan 13.

Reference Type BACKGROUND
PMID: 25586156 (View on PubMed)

Sato K, Kumar A, Jones BM, Mick SL, Krishnaswamy A, Grimm RA, Desai MY, Griffin BP, Rodriguez LL, Kapadia SR, Obuchowski NA, Popovic ZB. Reversibility of Cardiac Function Predicts Outcome After Transcatheter Aortic Valve Replacement in Patients With Severe Aortic Stenosis. J Am Heart Assoc. 2017 Jul 11;6(7):e005798. doi: 10.1161/JAHA.117.005798.

Reference Type BACKGROUND
PMID: 28698259 (View on PubMed)

Han D, Tamarappoo B, Klein E, Tyler J, Chakravarty T, Otaki Y, Miller R, Eisenberg E, Park R, Singh S, Shiota T, Siegel R, Stegic J, Salseth T, Cheng W, Dey D, Thomson L, Berman D, Makkar R, Friedman J. Computed tomography angiography-derived extracellular volume fraction predicts early recovery of left ventricular systolic function after transcatheter aortic valve replacement. Eur Heart J Cardiovasc Imaging. 2021 Jan 22;22(2):179-185. doi: 10.1093/ehjci/jeaa310.

Reference Type BACKGROUND
PMID: 33324979 (View on PubMed)

Jeong YJ, Ahn JM, Kang DY, Park H, Ko E, Kim HJ, Kim JB, Choo SJ, Lee SA, Park SJ, Kim DH, Park DW. Incidence, Predictors, and Prognostic Impact of Immediate Improvement in Left Ventricular Systolic Function After Transcatheter Aortic Valve Implantation. Am J Cardiol. 2021 Aug 1;152:99-105. doi: 10.1016/j.amjcard.2021.04.037. Epub 2021 Jun 11.

Reference Type BACKGROUND
PMID: 34127247 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

TAVR

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.