Status:
RECRUITING
STretch and Myocardial Characterization in Arrythmogenic Mitral Valve Prolapse-2
Lead Sponsor:
Central Hospital, Nancy, France
Conditions:
Mitral Valve Prolapse
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
Mitral valve prolapse (MVP) is a frequent affection of the mitral valve with a prevalence of 2-3% in the general population. This valvular disease is generally considered as benign, but may at term ev...
Eligibility Criteria
Inclusion
- Patient over 18 years old,
- Patient with mitral valve prolapse,
- Patient who has received full information about the organization of the research and has signed an informed consent,
- Patient affiliated to or beneficiary of a social security insurance,
- Patient who has completed a prior clinical examination adapted to the research and who does not show any contraindication to the planned examinations
Exclusion
- Stage of the disease: Patients with MVP with severe mitral regurgitation with a surgical indication as defined by current recommendations will not be included in the study,
- Presence of severe rhythm disorders requiring the implantation of a defibrillator (cardiorespiratory arrest recovered, sudden death recovered, etc.),
- Performance of an injected MRI in the month preceding the MRI scheduled during visit n°1,
- Previously diagnosed cardiopathy that may be responsible for myocardial damage (ventricular remodeling, alteration of left ventricular systolic function, fibrosis, etc.) and that may disrupt the interpretation of results (infarction, amyloidosis, systemic scleroderma, significant aortic valvulopathy, etc.).
- Contraindication to MRI examination, particularly in the presence of an implantable pacemaker or defibrillator, implanted pump, cochlear implants, neurosurgical clips, intraorbital or encephalic metallic foreign bodies,
- Claustrophobia or morphotype that does not allow MRI to be performed,
- Motor or mental disability,
- Renal impairment that does not allow the injection of Gadolinium-based contrast media (DOTAREM® or equivalent in the study). If there is any doubt as to the patient's renal function, a plasma creatinine determination will be performed for MRI to ensure the absence of renal failure,
- Hypersensitivity to gadoteric acid, meglumine, or any gadolinium-containing drug.
- Women of childbearing age who do not have effective contraception,
- Persons referred to in Articles L. 1121-5 to L1121-8 of the Public Health Code.
Key Trial Info
Start Date :
August 30 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 1 2027
Estimated Enrollment :
280 Patients enrolled
Trial Details
Trial ID
NCT04852731
Start Date
August 30 2021
End Date
July 1 2027
Last Update
August 9 2022
Active Locations (1)
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1
Nancy University Hospital
Vandœuvre-lès-Nancy, France, 54511