An observational study in Mitral Valve Insufficiency, Left Ventricular Systolic Dysfunction and Mitral Valve Prolapse, sponsored by Institut für Pharmakologie und Präventive Medizin. Completed at 6 sites in Germany. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-09-28.
Sponsored by Institut für Pharmakologie und Präventive Medizin · Observational
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.
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).
468 studies on the registry are indexed under Mitral Valve Insufficiency; 164 are open to participants now.
This study's enrollment of 105 is below the median of 157 across 168 observational studies indexed under Mitral Valve Insufficiency.
Browse Mitral Valve Insufficiency studies →Institut für Pharmakologie und Präventive Medizin is the lead sponsor of 30 studies on the registry; 4 are open to participants now.
Counted across the registry records on this site, refreshed daily.
patients presenting at participating hospitals with mitral valve dysfunction type III b who give written consent to participate in the registry
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
LVEF (left ventricular ejection fraction)
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patients with functional mitral insufficiency with restricted leaflet movement during systole (type IIIb Carpentier) undergoing operative reconstruction (mitral valve repair)
Procedure: mitral valve repair
operative reconstruction
recurrent mitral valve insufficiency > grade 2
see above
Time frame: 2 years
MACCE
major adverse cardiovascular and cerebrovascular events
Time frame: 1 year
re-intervention at mitral valve
see above
Time frame: 2 years
device therapy (e. g. left ventricular auxiliary device or heart transplant) due to progressive heart failure
see above
Time frame: 2 years
cardiovascular mortality
see above
Time frame: 2 years
re-hospitalisation due to heart failure
see above
Time frame: 2 years
Plan to share: No — no IPD will be made available
No publications or documents are linked to this record.
This study is completed, as verified in Sep 2023. You cannot join it, but the record below documents what was studied.
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Institut für Pharmakologie und Präventive Medizin