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

Myocardial Function of the Setonis Aortic Valve Before and Beyond Valve

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03686527
Acronym
AOMYOC
Enrollment
277
Registered
2018-09-27
Start date
2018-01-11
Completion date
2019-01-11
Last updated
2019-03-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Brief 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.

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

Sponsors

Rennes University Hospital
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

* 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

Design outcomes

Primary

MeasureTime frame
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.1 day of inclusion

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026