Left Ventricular Systolic FunctionNCT05069168
Predictors of Left Ventricular Systolic Function Recovery After Transcatheter Aortic Valve Replacement
An observational study of Left Ventricular Systolic Function, run by Assiut University at 1 site in Egypt.
Trial summary
Investigate the preprocedural predictors of left ventricular systolic function Recovery after TAVR Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Left Ventricular Systolic Function
- What is being tested?
- Echocardiography before and after TAVR
- How many people
- 75 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Dec 2023to 30 Dec 2024
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: patients with symptomatic severe aortic stenosis eligible for TAVR with LV systolic function less than 50%
Who may be able to join
- patients with symptomatic severe aortic stenosis eligible for TAVR with LV systolic function less than 50%.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Predictors of Left Ventricular Systolic Function Recovery After Transcatheter Aortic Valve
Investigate the preprocedural predictors of left ventricular systolic function Recovery after TAVR
Read the detailed description
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
- Left Ventricular Systolic Function
- Being tested
- Echocardiography before and after TAVR
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Echocardiography before and after TAVRDiagnostic test
Also called cardiac computed tomography and coronary angiography
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)
| Study group | Role | What they receive |
|---|---|---|
| LVEFrecovery | patient who shows improvement of left ventricular systolic function Receives: Diagnostic Test: Echocardiography before and after TAVR | |
| Non LVEF recovery | patient who don't show improvement of left ventricular systolic function Receives: Diagnostic Test: Echocardiography before and after TAVR |
What is being measured
The primary outcome is the main question the study is designed to answer.
left ventricular systolic function recovery by ejection fraction
absolute increase of ≥10% in EF compared with baseline
Measured: 30 days post TAVR
left ventricular systolic function recovery by STE
Myocardial recovery by STE is defined as a ≥20% relative increase in the magnitude of global longitudinal strain compared with baseline
Measured: 30 days post TAVR
Secondary outcomes (1)
Quality of life assessment
NIHA class .
Measured: 30days post TAVR
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2021
- Study start1 Dec 2023
- Primary completion30 Nov 2024
- Study completion30 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Left Ventricular Systolic FunctionStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- 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
- Case only
- Time perspective
- Retrospective
- Enrolment
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Anwar S Helen, Assiut University
- Investigators
- Hatem A Helmy, Study director, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05069168
- Sponsor's protocol ID
- TAVR
- Status last verified
- Feb 2024
- First submitted
- 12 Sep 2021
- Last updated
- 30 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 25586156Sato 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.
PubMed 28698259Han 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.
PubMed 33324979Jeong 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.
PubMed 34127247
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Predictors of Left Ventricular Systolic Function Recovery After Transcatheter Aortic Valve
- ClinicalTrials.gov ID
- NCT05069168
- Acronym / sponsor ID
- TAVR
- Conditions
- Left Ventricular Systolic Function
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Dec 2023 (actual)
- Primary completion
- 30 Nov 2024 (actual)
- Study completion
- 30 Dec 2024 (actual)
- First posted
- 6 Oct 2021 (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.
Investigate the preprocedural predictors of left ventricular systolic function Recovery after TAVR
Detailed description
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.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| LVEFrecovery | – | Diagnostic Test: Echocardiography before and after TAVRpatient who shows improvement of left ventricular systolic function |
| Non LVEF recovery | – | Diagnostic Test: Echocardiography before and after TAVRpatient who don't show improvement of left ventricular systolic function |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- patients with symptomatic severe aortic stenosis eligible for TAVR with LV systolic function less than 50%
Key inclusion criteria (1 listed)
- patients with symptomatic severe aortic stenosis eligible for TAVR with LV systolic function less than 50%.
Key exclusion criteria (5 listed)
- 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
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 |
|---|---|---|
| Echocardiography before and after TAVRAlso: cardiac computed tomography and coronary angiographyEvaluation 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) | Diagnostic test | LVEFrecovery, Non LVEF recovery |
Primary outcome
left ventricular systolic function recovery by ejection fraction
Time frame: 30 days post TAVR
absolute increase of ≥10% in EF compared with baseline
left ventricular systolic function recovery by STE
Time frame: 30 days post TAVR
Myocardial recovery by STE is defined as a ≥20% relative increase in the magnitude of global longitudinal strain compared with baseline
1 secondary outcome
Quality of life assessment
Time frame: 30days post TAVR
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 30 Jan 2025.
- Background: PubMed 25586156Passeri 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.
- Background: PubMed 28698259Sato 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.
- Background: PubMed 33324979Han 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.
- Background: PubMed 34127247Jeong 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.
- 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.
Hatem A Helmy study director
Assiut University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Left Ventricular Systolic Function, run by Assiut University at 1 site in Egypt.
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 5 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 30 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. 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?
left ventricular systolic function recovery by ejection fraction (time frame: 30 days post TAVR). The study lists 2 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 NCT05069168, which also lists 4 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 30 Jan 2025.