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CompletedNCT03686527AOMYOCUpdated Mar 26, 2019

Myocardial Function of the Setonis Aortic Valve Before and Beyond Valve Replacement

An observational study in Myocardial Function of the Stenosis Aortic Valve Before and Beyond Valve Replacement, sponsored by Rennes University Hospital. Completed at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-03-26.

Sponsored by Rennes University Hospital · Observational

Study type
Observational
Model
Case-only
Time perspective
Prospective
Enrollment
277
Ages
18 Years and older
Sex
All
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Study summary

Study the consequences on heart muscle of the stenosis aortic valve before and after the replacement procedure, the repercussion on heart. Study the impact on the heart of "sick" valve can affect on "well-being" and prognosis in the year following the surgery.

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Conditions studied

  • Myocardial Function of the Stenosis Aortic Valve Before and Beyond Valve Replacement

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03

In context

Aortic Valve Stenosis

985 studies on the registry are indexed under Aortic Valve Stenosis; 283 are open to participants now.

This study's enrollment of 277 is above the median of 200 across 424 observational studies indexed under Aortic Valve Stenosis.

Browse Aortic Valve Stenosis studies →

Lead sponsor

Rennes University Hospital is the lead sponsor of 440 studies on the registry; 51 are open to participants now.

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

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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 tight aortic stenosis with an indication of surgical treatment.

Inclusion criteria

  • major patient freely accepting to participate in the study
  • non-opposition signed
  • aortic surface \<1cm² or \<0.6cm² / m² of indication surgical restraint
  • oriented to short interventional management surgical term
  • LVEF Left ventricular ejection fraction> 50%
  • In the subgroup "MRI-fibrosis", absence of indication for performing MRI

Exclusion criteria

Exclusion Criteria:

  • patient under guardianship, curatorship or safeguard of justice
  • minor patient
  • pregnant woman
  • patient with significant polyvalvulopathy for which it is from the start programmed more than aortic valve replacement
  • patient with severe coronary artery disease requiring revascularization
  • allergy to the contrast product
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Study design

Observational model
Case-only
Time perspective
Prospective
Enrollment
277 participants (actual)
Patient registry
No

Groups and cohorts

  • Echocardiography

    Procedure: stenosis aortic valve

  • MRI Fibrosis

    Procedure: stenosis aortic valve

Interventions

  • Procedurestenosis aortic valve

    The exams to be realized : * a clinical examination with blood pressure * a 12-lead surface electrocardiogram * a standard biological assessment including NTproBNP (Brain Natriuretic Peptide) * Transthoracic echocardiography at baseline and 12 months after the aortic valve intervention on the (according to recommendations) * a cardiac MRI looking for fibrosis myocardial

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What researchers measure

Primary outcomes

  1. The primary endpoint is a composite endpoint: all-cause death, cardiovascular hospitalization: cardiac decompensation, atrial fibrillation within 12 months of surgical or percutaneous aortic valve replacement.

    Time frame: 1 day of inclusion

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Study locations

1 site
  • CHU Rennes
    Rennes, Bretagne 35000, France
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 26, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT03686527
Lead sponsor
Rennes University Hospital
Responsible party
Sponsor
First posted
Sep 27, 2018
Start date
Jan 11, 2018
Primary completion
Jan 11, 2019
Completion
Jan 11, 2019
Last update
Mar 26, 2019

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 Sep 2018. You cannot join it, but the record below documents what was studied.

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