Operative Mitral Valve Reconstruction in Functional mv Insufficiency With Reduced Systolic Ventricle Function

Completed

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

• Registration Number: NCT03470155
• Lead Sponsor: Institut für Pharmakologie und Präventive Medizin

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 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.

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 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 Timeline

• Study First Submitted: 2018-03-12
• Study First Submitted QC: 2018-03-12
• Study First Posted: 2018-03-19
• Study Start: 2018-06-05
• Primary Completion: 2020-07-15
• Study Completion: 2023-07-31
• Status Verified: 2023-09
• Last Update Submitted: 2023-09-27
• Last Update Posted: 2023-09-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 105

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
recurrent mitral valve insufficiency > grade 2	2 years	see above

Secondary Outcome Measures

Name	Time	Method
MACCE	1 year	major adverse cardiovascular and cerebrovascular events
re-intervention at mitral valve	2 years	see above
cardiovascular mortality	2 years	see above
device therapy (e. g. left ventricular auxiliary device or heart transplant) due to progressive heart failure	2 years	see above
re-hospitalisation due to heart failure	2 years	see above

Trial Locations

Locations (6)

Herzzentrum Leipzig; 🇩🇪 Leipzig, Sachsen, Germany

Zentralklinik Bad Berka; 🇩🇪 Bad Berka, Germany

Charité - Klinik für kardiovaskuläre Chirurgie; 🇩🇪 Berlin, Germany

Universitätsklinikum Frankfurt; 🇩🇪 Frankfurt, Germany

Klinik und Poliklinik für Herz- und Gefäßchirurgie am UHZ am UKE; 🇩🇪 Hamburg, Germany

Deutsches Herzzentrum München; 🇩🇪 München, Germany