Clinical trial NCT03470155: Operative Mitral Valve Reconstruction in Functional mv Insufficiency With Reduced Systolic Ventricle Function
Official title: Operative Mitralklappenrekonstruktion Bei Funktionellen Mitralklappenvitien Bei Reduzierter Systolischer Ventrikelfunktion
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Mitral Valve Insufficiency
Left Ventricular Systolic Dysfunction
Mitral Valve Prolapse
Keywords: annuloplasty mitral valve
reduced LV function
Lead sponsor: Institut für Pharmakologie und Präventive Medizin
Sponsor class: NETWORK
First posted: 2018-03-19
Enrollment: 105
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients presenting at participating hospitals with mitral valve dysfunction type III b who give written consent to participate in the registry

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).

Eligibility criteria: 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

Primary outcomes:
measure: recurrent mitral valve insufficiency > grade 2
timeFrame: 2 years
Secondary outcomes:
measure: MACCE
timeFrame: 1 year
measure: re-intervention at mitral valve
timeFrame: 2 years
measure: device therapy (e. g. left ventricular auxiliary device or heart transplant) due to progressive heart failure
timeFrame: 2 years
measure: cardiovascular mortality
timeFrame: 2 years
measure: re-hospitalisation due to heart failure
timeFrame: 2 years
Other outcomes:
Locations:
city: Leipzig
country: Germany
facility: Herzzentrum Leipzig
state: Sachsen
city: Bad Berka
country: Germany
facility: Zentralklinik Bad Berka
city: Berlin
country: Germany
facility: Charité - Klinik für kardiovaskuläre Chirurgie
city: Frankfurt
country: Germany
facility: Universitätsklinikum Frankfurt
city: Hamburg
country: Germany
facility: Klinik und Poliklinik für Herz- und Gefäßchirurgie am UHZ am UKE
city: München
country: Germany
facility: Deutsches Herzzentrum München
Study officials:
affiliation: Universitäres Herzzentrum Hamburg am UKE
name: Evaldas Girdauskas, MD
role: PRINCIPAL_INVESTIGATOR
References: