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

Operative Mitralklappenrekonstruktion Bei Funktionellen Mitralklappenvitien Bei Reduzierter Systolischer Ventrikelfunktion

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03470155
Acronym
REFORM-MR
Enrollment
105
Registered
2018-03-19
Start date
2018-06-05
Completion date
2023-07-31
Last updated
2023-09-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Left Ventricular Systolic Dysfunction, Mitral Valve Insufficiency, Mitral Valve Prolapse

Keywords

annuloplasty mitral valve, reduced LV function

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).

Interventions

operative reconstruction

Sponsors

Institut für Pharmakologie und Präventive Medizin
Lead SponsorNETWORK

Study design

Observational model
CASE_ONLY
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
recurrent mitral valve insufficiency > grade 22 yearssee above

Secondary

MeasureTime frameDescription
MACCE1 yearmajor adverse cardiovascular and cerebrovascular events
re-intervention at mitral valve2 yearssee above
device therapy (e. g. left ventricular auxiliary device or heart transplant) due to progressive heart failure2 yearssee above
cardiovascular mortality2 yearssee above
re-hospitalisation due to heart failure2 yearssee above

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 10, 2026