Researchers measure heart stiffness during surgery to understand aortic stenosis
NCT ID NCT04358692
First seen Jun 26, 2026 · Last updated Jun 26, 2026
Summary
This study used a special ultrasound technique called elastography to measure heart muscle stiffness during planned aortic valve replacement surgery. Researchers compared stiffness in patients with aortic stenosis to those having bypass surgery. The goal was to see if aortic stenosis makes the heart stiffer, not to test a new treatment.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
-
98 people
The number who actually took part.
- Started
-
Jun 2020
- Finished
-
Jun 2024
- Lead sponsor
-
Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
18 years and older
- Sex
-
Anyone
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * 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 Exclusion Criteria: * Group II: coronary bypass 1. Ratio in TM mode of the wall thickness over the radius of the left ventricle (h / r \[0.45\]) confirmed by the TTE; 2. Scar of myocardial infarction defined by an ECG anomaly and / or hypo-akinesia on TTE, and / or a late enhancement in MRI; 3. Acute coronary syndrome less than 3 months old; 4. Significant aortic stenosis (Vmax\> 1.5 m / s); 5. Anomaly of segmental kinetics; 6. 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
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for Aortic valve stenosis are added.
Genom att skicka in godkänner du våra Användarvillkor
Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
-
CHU Caen
Caen, France
-
CHU de Rouen
Rouen, France
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Can aggressive blood pressure treatment slow aortic valve disease?
- Why do animal heart valves wear out? immune system under investigation
- One scan to rule them all? new CT aims to replace multiple heart tests
- Which heart valve design wins for small aortic openings?
- Can a less invasive valve replacement tame a failing aortic valve?
- Can a new heart valve match the safety of proven ones?