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Operative Mitral Valve Reconstruction in Functional mv Insufficiency With Reduced Systolic Ventricle Function — REFORM-MR  

Mitral Valve Insufficiency Clinical Trial

Official title:
Operative Mitralklappenrekonstruktion Bei Funktionellen Mitralklappenvitien Bei Reduzierter Systolischer Ventrikelfunktion

Clinical Trial 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 LV ejection fraction (EF). The registry will document the underlying pathology by using transthoracal echo cardiography (TTE) with analysis of common tenting parameters. OP strategies, data and outcomes will be documented, as well as follow-up data for echocardiography, quality of life and MACCE outcomes after 6 months, 1 and 2 years.

Clinical Trial 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 TTE with analysis of tenting parameters. In patients without contraindications, functional preoperative MRT to determine the functional reserve of ventricular function. Documentation of the quality of life of the patients using the SF12 questionnaire before and after intervention. Documentation of follow-up data (SF12, TTE, NT-pro BNP) at 6 months, 1 and 2 years. Development of operative strategies to improve long-term outcomes in patients with severe LV dilation (typically accompanied by function mitral insufficiency type IIIb). ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03470155
Study type Observational [Patient Registry]
Source Institut für Pharmakologie und Präventive Medizin
Contact
Status Completed
Phase
Start date June 5, 2018
Completion date July 31, 2023
View Details
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