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

Institut für Pharmakologie und Präventive Medizin

Status: Completed

Conditions: Mitral Valve Insufficiency; Left Ventricular Systolic Dysfunction; Mitral Valve Prolapse

Treatments: Procedure: mitral valve repair

Study type: Observational

Funder types: NETWORK

Identifiers

NCT03470155

REFORM-MR

Details and patient eligibility

About

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.

Full 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).

Enrollment: 105 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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 criteria

• prolaps of leaflets (type II mitral regurgitation)
• combination intervention with aortic valve repair or replacement
• re-operation at mitral valve

Trial design

105 participants in 1 patient group

functional mitral insufficiency op

Description:

Patients with functional mitral insufficiency with restricted leaflet movement during systole (type IIIb Carpentier) undergoing operative reconstruction (mitral valve repair)

Treatment:

Procedure: mitral valve repair