Status:
COMPLETED
Impact of Preoperative Myocardial Fibrosis Related to Mitral Valve Prolapse on Postoperative Left Ventricular Remodeling
Lead Sponsor:
Hospices Civils de Lyon
Conditions:
Regurgitation, Mitral
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
Primary mitral regurgitation (MR) is the most common valvular disease in western countries. The MR mechanism is often related to a mitral valve prolapse (MVP) defined as a single or bi-leaflet prolaps...
Eligibility Criteria
Inclusion
- Adults (≥ 18 years old)
- Patients candidate for mitral valve repair after validation by the local Heart-Team
- Severe symptomatic primary Mitral Regurgitation (MR), due to:
- Posterior or bileaflet prolapse, with
- Criteria of advance disease (i.e. existence of fibrosis):
- Effective Regurgitant Orifice Area (EROA) \> 35 mm2 - Regurgitant volume \> 45 mL
- Left ventricular end-diastolic diameter \>55 mm
- Left atrium volume index \>60 mL/m2
- Pulmonary artery systolic pressure \> 30mmHg
- Patients who have provided written informed consent to participate in the study.
- Patients affiliated with a social health insurance.
Exclusion
- Patients with contraindication for mitral valve repair, including:
- Patients with secondary MR; and
- Calcified leaflets segments.
- Patients with contraindication for a minimally invasive approach including:
- Previous heart surgery;
- Previous right lung surgery; or
- Vascular access contraindications.
- Patients with contraindication for CMR imaging:
- Patients without sinus rhythm
- Regular MRI contraindications (e.g. a claustrophobia, a pacemaker, defibrillator or metallic (ferromagnetic) body, a known allergy to gadolinium)
- Contraindication for Gadolinium infusion: glomerular filtration rate (GFR) \<30 ml / min
- Patients unable to understand the purpose of the study
- Patients participating in another trial that would interfere with this study
- Female patients who are pregnant, lactating or women of child-bearing potential without highly effective methods of contraception
- Patients under judicial protection
Key Trial Info
Start Date :
June 28 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 15 2024
Estimated Enrollment :
5 Patients enrolled
Trial Details
Trial ID
NCT05284058
Start Date
June 28 2022
End Date
July 15 2024
Last Update
December 2 2024
Active Locations (1)
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1
Hôpital Pneumologique et Cardiovasculaire Louis Pradel - Hospices Civils de Lyon - Groupement Hospitalier Est
Bron, France, 69677