Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 11:58 PM
Ignite Modification Date:
2025-12-24 @ 11:58 PM
NCT ID:
NCT05284058
Eligibility Criteria:
Inclusion Criteria:
* 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 Criteria:
* 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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT05284058
Study Brief:
Protocol Section:
NCT05284058