Aortic Valve StenosisELASTOP-ASNCT04358692
Measurement of Myocardial Stiffness Using Elastometry in Patients With Aortic Stenosis
A study testing Aixplorer Mach30 in people with Aortic Valve Stenosis, run by University Hospital, Rouen at 2 sites in France.
Trial summary
Elastography is a new non-invasive medical technique for measuring the stiffness at a distance from a tissue. Recent advances in the development of elastography sequences for cardiac exploration suggest a more clinical approach to cardiac elastography. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Aortic Valve Stenosis
- What is being tested?
- Aixplorer Mach30
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 98 participants
- Where
- 2 sitesFrance
- Study dates
- 30 Jun 2020to 14 Jun 2024
- Phase
- Interventional
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Group I (aortic stenosis):
- 1. Patient undergoing planned surgical aortic valve replacement (SAVR) for aortic stenosis (aortic valve area <1cm² or an aortic valve area index <0.6 cm² / m²);
- Group II: coronary bypass 2. Patient undergoing planned myocardial revascularization surgery (coronary bypass);
- Groups I and II 3. Patient over 18 years of age; 4. Patient having read and understood the information letter and having signed the consent form; 5. Patient affiliated or benefiting from a health insurance scheme
Who cannot join
- Group II: coronary bypass
- Ratio in TM mode of the wall thickness over the radius of the left ventricle (h / r [0.45]) confirmed by the TTE;
- Scar of myocardial infarction defined by an ECG anomaly and / or hypo-akinesia on TTE, and / or a late enhancement in MRI;
- Acute coronary syndrome less than 3 months old;
- Significant aortic stenosis (Vmax> 1.5 m / s);
- Anomaly of segmental kinetics;
- Presence of left ventricular hypertrophy
- Groups I and II 7. Mitral valve disease (> 1/4 confirmed by TTE); 8. Aortic insufficiency (> 1/4 confirmed by TTE); 9. Left ventricle ejection fraction (LVEF) <50% confirmed by TTE; 10. Hospitalization for heart failure less than 3 months old; 11. Urgent surgery; 12. Infiltrative heart disease; 13. Hostile pericardium defined by a history of mediastinal radiotherapy, tamponade or complicated pericarditis; 14. Decompensated or severe arterial hypertension. 15. Functional inability to walk preventing the performance of the walk test; 16. Proven pregnant woman (positive urine pregnancy test) or breastfeeding or absence of effective contraception (as defined by the WHO) or postmenopausal woman without confirmation diagnosis obtained (amenorrhea not medically induced for at least 12 months before the initiation visit) ; 17. Person deprived of their liberty by an administrative or judicial decision or person placed under the protection of justice / guardianship or curatorship 18. History of illness or psychological or sensory abnormality likely to prevent the subject from fully understanding the conditions required for participating in the protocol or preventing him from giving his informed consent
Trial locations and contacts
2 sites in 1 country.
About this study
Official title: Epicardial Measurement of Myocardial Stiffness on Beating Heart and Non-beating Heart During a Programmed Surgical Aortic Valve Replacement for Aortic Stenosis
Elastography is a new non-invasive medical technique for measuring the stiffness at a distance from a tissue. Recent advances in the development of elastography sequences for cardiac exploration suggest a more clinical approach to cardiac elastography. This study propose to compare myocardial stiffness of a group of coronary bypass patients without hypertrophic left ventricular remodeling or sequelae of myocardial infarction versus a group of patients who should benefit from a surgical aortic valve replacement for aortic stenosis.
The hypothesis is that the physiological adaptation to pressure overload constituted by aortic stenosis is responsible for a significant increase in myocardial stiffness compared to a reference group.
- Conditions
- Aortic Valve Stenosis
- Being tested
- Aixplorer Mach30
- Keywords
- Elastography, Myocardial stiffness, Surgical Aortic Valve Replacement
- 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.
Aixplorer Mach30Device
To measure myocardial stiffness by ShearWave elastography on not beating heart
| Study group | Role | What they receive |
|---|---|---|
| Surgical Aortic Valve Replacement | Experimental | Patients with aortic stenosis Receives: Device: Aixplorer Mach30 |
| Reference | Other | Coronary bypass patients without hypertrophic left ventricular remodeling or sequelae of myocardial infarction Receives: Device: Aixplorer Mach30 |
What is being measured
The primary outcome is the main question the study is designed to answer.
to compare myocardial stiffness by ShearWave elastography on not beating heart in two groups of patients referred for surgery
The main outcome measure is evaluated by ShearWave elastography with the measurement of Young modulus on non-beating heart
Measured: Day 1
Secondary outcomes (6)
To compare the diastolic myocardial stiffness of the beating heart with the myocardial stiffness of the non-beating heart
This outcome measure is evaluated by ShearWave elastography with the measurement of Young modulus on non-beating heart
Measured: Day 1
To compare epicardial and trans-thoracic diastolic myocardial stiffness
This outcome measure is evaluated by elastography using the measurement of Young modulus in epicardial (using the linear probe) and transthoracic (using the scanning probe).
Measured: Day 1
Correlation between the diastolic myocardial stiffness of the beating heart and the non-beating heart with conventional diastolic indices
This outcome measure is evaluated:
- by ShearWave elastography with the measurement of Young modulus on non-beating heart
- by conventional ultrasound criteria (peak e', peak E, volume of the left atrium calculated by simpson biplanes, maximum velocity of tricuspid insufficiency).
Measured: Day 1
Correlation between the diastolic myocardial stiffness of the beating heart and the non-beating heart with heart failure parameters
This outcome measure is evaluated:
- by ShearWave elastography with the measurement of Young modulus on non-beating heart
- by heart failure parameters defined by NYHA class, the walking test and the BNP assay
Measured: Day 1
Correlation between the diastolic myocardial stiffness of the beating heart and the non-beating heart with left ventricular mass indexed to the body surface
This outcome measure is evaluated:
- by ShearWave elastography with the measurement of Young modulus on non-beating heart
- by LV mass indexed to the body surface calculated by the cardiac mass measuring by ultrasound indexed to the body surface
Measured: Day 1
Correlation between the diastolic myocardial stiffness of the beating heart and the non-beating heart and the prognosis
This outcome measure is evaluated:
- by ShearWave elastography with the measurement of Young modulus on non-beating heart
- by a combined index combining all rehospitalization for heart failure, increase in heart failure treatment and cardiac death
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2020
- Study start30 Jun 2020
- Primary completion14 Jun 2024
- Study completion14 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Aortic Valve StenosisStudies of the same condition, open and under way.
- More trials run by University Hospital, RouenThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 98 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Rouen
- Sponsor type
- University, hospital or other
- Collaborators
- University Hospital, Caen
- Responsible party
- Sponsor
- Investigators
- Eric Saloux, MD, Study director, University Hospital, Caen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04358692
- Sponsor's protocol ID
- 2019/0254/HP
- Acronym
- ELASTOP-AS
- Status last verified
- Apr 2025
- First submitted
- 9 Apr 2020
- Last updated
- 10 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Epicardial Measurement of Myocardial Stiffness on Beating Heart and Non-beating Heart During a Programmed Surgical Aortic Valve Replacement for Aortic Stenosis
- ClinicalTrials.gov ID
- NCT04358692
- Acronym / sponsor ID
- ELASTOP-AS / 2019/0254/HP
- Conditions
- Aortic Valve Stenosis
- Keywords
- Elastography, Myocardial stiffness, Surgical Aortic Valve Replacement
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 98 participants (actual)
- Lead sponsor
- University Hospital, RouenUniversity, hospital or other
- Collaborators
- University Hospital, Caen
- Study start
- 30 Jun 2020 (actual)
- Primary completion
- 14 Jun 2024 (actual)
- Study completion
- 14 Jun 2024 (actual)
- First posted
- 24 Apr 2020 (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.
Elastography is a new non-invasive medical technique for measuring the stiffness at a distance from a tissue. Recent advances in the development of elastography sequences for cardiac exploration suggest a more clinical approach to cardiac elastography. This study propose to compare myocardial stiffness of a group of coronary bypass patients without hypertrophic left ventricular remodeling or sequelae of myocardial infarction versus a group of patients who should benefit from a surgical aortic valve replacement for aortic stenosis.
The hypothesis is that the physiological adaptation to pressure overload constituted by aortic stenosis is responsible for a significant increase in myocardial stiffness compared to a reference group.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Surgical Aortic Valve Replacement | Experimental | Device: Aixplorer Mach30Patients with aortic stenosis |
| Reference | Other | Device: Aixplorer Mach30Coronary bypass patients without hypertrophic left ventricular remodeling or sequelae of myocardial infarction |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Group I (aortic stenosis):
- 1. Patient undergoing planned surgical aortic valve replacement (SAVR) for aortic stenosis (aortic valve area <1cm² or an aortic valve area index <0.6 cm² / m²);
- Group II: coronary bypass 2. Patient undergoing planned myocardial revascularization surgery (coronary bypass);
- Groups I and II 3. Patient over 18 years of age; 4. Patient having read and understood the information letter and having signed the consent form; 5. Patient affiliated or benefiting from a health insurance scheme
Key exclusion criteria (8 listed)
- Group II: coronary bypass
- Groups I and II 7. Mitral valve disease (> 1/4 confirmed by TTE); 8. Aortic insufficiency (> 1/4 confirmed by TTE); 9. Left ventricle ejection fraction (LVEF) <50% confirmed by TTE; 10. Hospitalization for heart failure less than 3 months old; 11. Urgent surgery; 12. Infiltrative heart disease; 13. Hostile pericardium defined by a history of mediastinal radiotherapy, tamponade or complicated pericarditis; 14. Decompensated or severe arterial hypertension. 15. Functional inability to walk preventing the performance of the walk test; 16. Proven pregnant woman (positive urine pregnancy test) or breastfeeding or absence of effective contraception (as defined by the WHO) or postmenopausal woman without confirmation diagnosis obtained (amenorrhea not medically induced for at least 12 months before the initiation visit) ; 17. Person deprived of their liberty by an administrative or judicial decision or person placed under the protection of justice / guardianship or curatorship 18. History of illness or psychological or sensory abnormality likely to prevent the subject from fully understanding the conditions required for participating in the protocol or preventing him from giving his informed consent
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 |
|---|---|---|
| Aixplorer Mach30To measure myocardial stiffness by ShearWave elastography on not beating heart | Device | Reference, Surgical Aortic Valve Replacement |
Primary outcome
to compare myocardial stiffness by ShearWave elastography on not beating heart in two groups of patients referred for surgery
Time frame: Day 1
The main outcome measure is evaluated by ShearWave elastography with the measurement of Young modulus on non-beating heart
6 secondary outcomes
To compare the diastolic myocardial stiffness of the beating heart with the myocardial stiffness of the non-beating heart
Time frame: Day 1
To compare epicardial and trans-thoracic diastolic myocardial stiffness
Time frame: Day 1
Correlation between the diastolic myocardial stiffness of the beating heart and the non-beating heart with conventional diastolic indices
Time frame: Day 1
Correlation between the diastolic myocardial stiffness of the beating heart and the non-beating heart with heart failure parameters
Time frame: Day 1
Correlation between the diastolic myocardial stiffness of the beating heart and the non-beating heart with left ventricular mass indexed to the body surface
Time frame: Day 1
Correlation between the diastolic myocardial stiffness of the beating heart and the non-beating heart and the prognosis
Time frame: 1 year
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 10 Sep 2025.
- 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.
Eric Saloux, MD study director
University Hospital, Caen
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Aixplorer Mach30 in people with Aortic Valve Stenosis, run by University Hospital, Rouen at 2 sites in France.
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 4 inclusion and 8 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 10 Sep 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 France. 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?
to compare myocardial stiffness by ShearWave elastography on not beating heart in two groups of patients referred for surgery (time frame: Day 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 10 Sep 2025.