Status:
WITHDRAWN
Acquisition of Objective Data During Transapical Neochordae Implantation
Lead Sponsor:
Hospices Civils de Lyon
Conditions:
Mitral Valve Insufficiency
Mitral Regurgitation
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
Mitral Valve repair (MVr) is the gold standard treatment for primary Mitral Regurgitation. Implantation of artificial Gore-Tex chordae (or neochordae implantation) is often used for MVr. The NeoChord...
Eligibility Criteria
Inclusion
- Adults (≥ 18 years old)
- Patient candidate for NeoChord procedure after validation by the local Heart-Team
- severe symptomatic MR due to a posterior prolapses, involving mainly the P2 segment (with a variable extension on P1 or P3, but never involving the commissures or the anterior leaflet). Also, a LAI (leaflet to annulus index) \>1,25 will be required.
- and considered as high-risk for conventional surgery (mainly because of frailty) after selection by our heart team.
- Patient who has provided his written informed consent to participate in the study
- Patient affiliated to a social health insurance.
Exclusion
- Patient with contraindication for NeoChord technic including:
- Patient with secondary MR
- LV dilatation with initial tethering
- Central component to regurgitant jet
- Calcified leaflets segments.
- Patient with contraindication for Cardiovascular Magnetic Resonance (CMR) imaging:
- Patients without sinus rhythm
- Regular MRI contraindications (e.g. a pacemaker, defibrillator or metallic (ferromagnetic) body, a known allergy to gadolinium)
- Contraindication for Gadolinium infusion : glomerular filtration rate (GFR) \<30 ml / min
- Patient unable to understand the purpose of the study
- Patient participating in another trial that would interfere with this study
- Female patient who is pregnant or lactating
- Patients under judicial protection
Key Trial Info
Start Date :
May 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2024
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT04709042
Start Date
May 1 2021
End Date
May 1 2024
Last Update
March 24 2022
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