Status:
COMPLETED
Operative Mitral Valve Reconstruction in Functional mv Insufficiency With Reduced Systolic Ventricle Function
Lead Sponsor:
Institut für Pharmakologie und Präventive Medizin
Conditions:
Mitral Valve Insufficiency
Left Ventricular Systolic Dysfunction
Eligibility:
All Genders
18+ years
Brief Summary
Functional mitral insufficiency poses a challenge with regard to the optimal time of intervention, particularly because they are frequently associated with left ventricular (LV) dilation and reduced L...
Detailed Description
Prospective enrolment of all patients with mitral valve insufficiency and restricted movement of leaflets during systole into a multicentric registry. Exact analysis of the underlying pathology using ...
Eligibility Criteria
Inclusion
- functional mitral valve insufficiency with reduced mobility of leaflets during systole (type IIIb) - effective regurgitation orifice area \> 20 mm2 / regurgitant volume \> 30 ml/beat
- left ventricular ejection fraction \<= 50% and /or left ventricular end-diastolic diameter \>= 60 mm
- tenting of the proximal and / or anterior mitral leaflets
Exclusion
- prolaps of leaflets (type II mitral regurgitation)
- combination intervention with aortic valve repair or replacement
- re-operation at mitral valve
Key Trial Info
Start Date :
June 5 2018
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
July 31 2023
Estimated Enrollment :
105 Patients enrolled
Trial Details
Trial ID
NCT03470155
Start Date
June 5 2018
End Date
July 31 2023
Last Update
September 28 2023
Active Locations (6)
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1
Herzzentrum Leipzig
Leipzig, Saxony, Germany, 04289
2
Zentralklinik Bad Berka
Bad Berka, Germany, 99437
3
Charité - Klinik für kardiovaskuläre Chirurgie
Berlin, Germany, 10117
4
Universitätsklinikum Frankfurt
Frankfurt, Germany