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CompletedNCT03411304Updated Nov 6, 2026

Aortic Stenosis: Determinants and Prognostic Value of Preoperative Left Ventricular Remodeling After Valvular Replacement

An observational study in Aortic Valve Stenosis, sponsored by University Hospital, Rouen. Completed at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-11-06.

Sponsored by University Hospital, Rouen · Observational

Updated Nov 6, 2026Now CompletedPrimary completion moved+1 moreGo to Updates ↓
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
440
Ages
18 Years and older
Sex
All
01

Study 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 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.

02

Conditions studied

  • Aortic Valve Stenosis

Keywords

  • Aortic valvular replacement
  • Aortic stenosis
  • Left ventricular remodeling
  • biomarkers
03

In context

Aortic Valve Stenosis

1,025 studies on the registry are indexed under Aortic Valve Stenosis; 293 are open to participants now.

This study's enrollment of 440 is above the median of 200 across 435 observational studies indexed under Aortic Valve Stenosis.

Browse Aortic Valve Stenosis studies →

Lead sponsor

University Hospital, Rouen is the lead sponsor of 418 studies on the registry; 106 are open to participants now.

Browse University Hospital, Rouen studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Patients with at least moderate aortic stenosis and in whom an intervention is programmed or indicated

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Aortic stenosis
  • Indication of Aortic Valve Replacement (Surgery or TAVI)

Exclusion criteria

Exclusion Criteria:

  • 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
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
440 participants (actual)
Patient registry
No
06

What researchers measure

Primary outcomes

  1. Occurrence of clinical events according to left ventricular remodeling

    Echocardiography and MRI

    Time frame: Year 1

  2. Occurrence of clinical events according to left ventricular remodeling

    Echocardiography and MRI

    Time frame: Year 2

  3. Occurrence of clinical events according to left ventricular remodeling

    Echocardiography and MRI

    Time frame: Year 3

  4. Occurrence of clinical events according to left ventricular remodeling

    Echocardiography and MRI

    Time frame: Year 4

Secondary outcomes

  1. Evolution of left ventricular remodeling after aortic valvular replacement

    Echocardiography and MRI

    Time frame: Year 1

  2. Prognostic value of persistence and type of left ventricular remodeling

    Echocardiography and MRI Occurence of clinical events

    Time frame: Year 1

  3. Prognostic value of fibrosis

    Echocardiography and MRI Occurence of clinical events

    Time frame: Year 1

  4. Prognostic value of biomarkers

    Time frame: Year 1

07

Study locations

1 site
08

Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedDate before it movedWhere the date was before it movedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Dec 2017 to primary completion in Nov 2025, 95 months.

Of 205 non-industry observational studies under Aortic Valve Stenosis, half reached primary completion within 45 months of starting (the median), counting those still running; a quarter within 23 and three quarters within 120. This study's 95 months is above that.

Counting every sponsor, half of 242 studies reached it within 42 months; a quarter within 23 and three quarters within 86.

Since we started tracking on Sep 25, 2026, the dates moved once, on Nov 6, 2026: primary completion Jun 2025 → Nov 2025 and completion Jun 2025 → Nov 2025.

Earlier changes are on the record history on ClinicalTrials.gov ↗

How these figures are worked out, and which studies are left out of them.

Registered
Aug 21, 2017
First posted
Jan 26, 2018
StartActual
Dec 5, 2017
Primary completionActual
Nov 13, 2025was Jun 2025
CompletionActual
Nov 13, 2025was Jun 2025
Last update
Nov 6, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Status
Active, not recruiting→Completed
changed Nov 6, 2026
Primary completion
Jun 2025→Nov 13, 2025 (actual)
Nov 6, 2026
Study completion
Jun 2025→Nov 13, 2025 (actual)
Nov 6, 2026
Show all 1 update
  1. Nov 6, 2026
    Active, not recruiting→Completed
    Primary completion Jun 2025→Nov 13, 2025 (now actual)
    Study completion Jun 2025→Nov 13, 2025 (now actual)
    + 3 other changes: verification date, oversight details and index terms

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

09

Registry details

Key details

Study ID
NCT03411304
Lead sponsor
University Hospital, Rouen
Responsible party
Sponsor
First posted
Jan 26, 2018
Start date
Dec 5, 2017
Primary completion
Nov 13, 2025
Completion
Nov 13, 2025
Last update
Nov 6, 2026

Study contacts

Helene Eltchaninoff, Pr
principal investigator · University Hospital, Rouen

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Nov 2026. You cannot join it, but the record below documents what was studied.

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Discussion

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