CompletedNot Applicable

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

Germany105 participantsStarted 2018-06-05

Plain-language 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.

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

recurrent mitral valve insufficiency > grade 2

Timeframe: 2 years

Trial details

NCT IDNCT03470155

SponsorInstitut für Pharmakologie und Präventive Medizin

Sponsor typeNETWORK

Study typeOBSERVATIONAL

Primary completion2020-07-15

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