Aortic Valve StenosisNCT03411304
Aortic Stenosis: Determinants and Prognostic Value of Preoperative Left Ventricular Remodeling After Valvular Replacement
An observational study of Aortic Valve Stenosis, run by University Hospital, Rouen at 1 site in France.
Trial summary
Aortic stenosis (AS) is the most frequent valvulopathy in Western countries. The prevalence of AS is constantly increasing due to the aging of the population. Although significant progress has been made in understanding the pathophysiological mechanisms underlying the onset and progression of AS, there is no medical… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Aortic Valve Stenosis
- How many people
- 440 participants
- Where
- 1 siteFrance
- Study dates
- 5 Dec 2017to 13 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with at least moderate aortic stenosis and in whom an intervention is programmed or indicated
Who may be able to join
- Aortic stenosis
- Indication of Aortic Valve Replacement (Surgery or TAVI)
Who cannot join
- Rheumatismal or congenital aortic stenosis
- Aortic insufficiency (grade >= 2/4)
- Associated valvulopathy (grade >= 2/4)
- Myocardial infarction antecedent
- Severe renal failure
- Cardiac surgery (Aorta abdominal) antecedent
- Complex congenital cardiopathy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Aortic Stenosis: Determinants and Prognostic Value of Preoperative Left Ventricular Remodeling After Valvular Replacement (AS-INTERVENTION)
Aortic stenosis (AS) is the most frequent valvulopathy in Western countries. The prevalence of AS is constantly increasing due to the aging of the population. Although significant progress has been made in understanding the pathophysiological mechanisms underlying the onset and progression of AS, there is no medical treatment to slow or prevent its progression. The only treatment available is Aortic Valve Replacement (AVR) performed by surgery or by catheterization (TAVI).
AS is associated with an increase of post-load which leads the left ventricular myocardium to hypertrophy. Associated with hypertrophy, myocardial fibrosis will gradually develop. Despite interesting data, many unknowns persist and remain to be identified.
The aim of the study is to characterize prospectively the left ventricular remodeling and assess its changes after AVR and within 1 year in 500 patients using clinical, biological, echocardiographic and MRI parameters.
- Conditions
- Aortic Valve Stenosis
- Keywords
- Aortic valvular replacement, Aortic stenosis, Left ventricular remodeling, biomarkers
- Medical subject headings
- Aortic Valve Stenosis, Ventricular Remodeling
What is being measured
The primary outcome is the main question the study is designed to answer.
Occurrence of clinical events according to left ventricular remodeling
Echocardiography and MRI
Measured: Year 1
Occurrence of clinical events according to left ventricular remodeling
Echocardiography and MRI
Measured: Year 2
Occurrence of clinical events according to left ventricular remodeling
Echocardiography and MRI
Measured: Year 3
Occurrence of clinical events according to left ventricular remodeling
Echocardiography and MRI
Measured: Year 4
Secondary outcomes (4)
Evolution of left ventricular remodeling after aortic valvular replacement
Echocardiography and MRI
Measured: Year 1
Prognostic value of persistence and type of left ventricular remodeling
Echocardiography and MRI Occurence of clinical events
Measured: Year 1
Prognostic value of fibrosis
Echocardiography and MRI Occurence of clinical events
Measured: Year 1
Prognostic value of biomarkers
Measured: Year 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2018
- Study start5 Dec 2017
- Primary completion13 Nov 2025
- Study completion13 Nov 2025
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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 440 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Rouen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Helene Eltchaninoff, Pr, Principal investigator, University Hospital, Rouen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03411304
- Sponsor's protocol ID
- 2017/080/HP
- Status last verified
- Nov 2026
- First submitted
- 21 Aug 2017
- Last updated
- 6 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Aortic Stenosis: Determinants and Prognostic Value of Preoperative Left Ventricular Remodeling After Valvular Replacement (AS-INTERVENTION)
- ClinicalTrials.gov ID
- NCT03411304
- Acronym / sponsor ID
- 2017/080/HP
- Conditions
- Aortic Valve Stenosis
- Keywords
- Aortic valvular replacement, Aortic stenosis, Left ventricular remodeling, biomarkers
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 440 participants (actual)
- Lead sponsor
- University Hospital, RouenUniversity, hospital or other
- Study start
- 5 Dec 2017 (actual)
- Primary completion
- 13 Nov 2025 (actual)
- Study completion
- 13 Nov 2025 (actual)
- First posted
- 26 Jan 2018 (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.
Aortic stenosis (AS) is the most frequent valvulopathy in Western countries. The prevalence of AS is constantly increasing due to the aging of the population. Although significant progress has been made in understanding the pathophysiological mechanisms underlying the onset and progression of AS, there is no medical treatment to slow or prevent its progression. The only treatment available is Aortic Valve Replacement (AVR) performed by surgery or by catheterization (TAVI).
AS is associated with an increase of post-load which leads the left ventricular myocardium to hypertrophy. Associated with hypertrophy, myocardial fibrosis will gradually develop. Despite interesting data, many unknowns persist and remain to be identified.
The aim of the study is to characterize prospectively the left ventricular remodeling and assess its changes after AVR and within 1 year in 500 patients using clinical, biological, echocardiographic and MRI parameters.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with at least moderate aortic stenosis and in whom an intervention is programmed or indicated
Key inclusion criteria (2 listed)
- Aortic stenosis
- Indication of Aortic Valve Replacement (Surgery or TAVI)
Key exclusion criteria (7 listed)
- Rheumatismal or congenital aortic stenosis
- Aortic insufficiency (grade >= 2/4)
- Associated valvulopathy (grade >= 2/4)
- Myocardial infarction antecedent
- Severe renal failure
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Occurrence of clinical events according to left ventricular remodeling
Time frame: Year 1
Echocardiography and MRI
Occurrence of clinical events according to left ventricular remodeling
Time frame: Year 2
Echocardiography and MRI
Occurrence of clinical events according to left ventricular remodeling
Time frame: Year 3
Echocardiography and MRI
Occurrence of clinical events according to left ventricular remodeling
Time frame: Year 4
Echocardiography and MRI
4 secondary outcomes
Evolution of left ventricular remodeling after aortic valvular replacement
Time frame: Year 1
Prognostic value of persistence and type of left ventricular remodeling
Time frame: Year 1
Prognostic value of fibrosis
Time frame: Year 1
Prognostic value of biomarkers
Time frame: Year 1
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 6 Nov 2026.
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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.
Helene Eltchaninoff, Pr principal investigator
University Hospital, Rouen
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 Aortic Valve Stenosis, run by University Hospital, Rouen at 1 site 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 2 inclusion and 7 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 6 Nov 2026. 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 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?
Occurrence of clinical events according to left ventricular remodeling (time frame: Year 1). 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?
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 6 Nov 2026.