An interventional study of Carpentier Edwards Physio 2 Complete flexible mitral ring and Simplici T Partial flexible mitral annuloplasty ring in Degenerative Mitral Valve Disease, sponsored by University Health Network, Toronto. Status unknown. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2017-09-25.
Sponsored by University Health Network, Toronto · Not applicable, Interventional, and Treatment
Recently published work has suggested that mitral valve annuloplasty ring type may affect the development of post-repair mitral stenosis resulting in adverse intracardiac hemodynamics and poor functional status. However, these results have not been comprehensively determined in a systematic manner on a general mitral valve repair population. As well, an underlying mechanism for these findings is not understood.
The investigators hypothesize that mitral valve repair with a complete annuloplasty ring (Carpentier-Edwards Physio II) when compared to repair with a partial annuloplasty ring (Simplici- T) may not necessarily result in elevated mitral gradients consistent with functional mitral stenosis (FMS). Currently no prospective data exists to test the hypothesis that a correctly sized, flexible complete annuloplasty ring has detrimental effects.
As 60% of annuloplasty rings used in surgical repair of degenerative mitral valve disease in North America utilizes one of the many forms of complete flexible rings available, this information is urgently required.
The investigators will evaluate: 1) the effect on mitral valve hemodynamics, 2) changes to mitral annular, valvular and subvalvular structure and function with 3D echocardiography, and 3) the effect on patient functional capacity at 1 year.
If FMS early post repair is a real phenomenon, the investigators hope to better understand the mechanisms through the use of advanced imaging techniques-namely 3D modeling of the mitral valvular apparatus, aortic mitral interactions and LV remodeling.
Exclusion Criteria:
Mitral Valve Annuloplasty Ring Repair using Carpentier Edwards Physio 2 Complete flexible mitral ring
Device: Carpentier Edwards Physio 2 Complete flexible mitral ring
Mitral Valve Annuloplasty Ring Repair using Simplici T Partial flexible mitral annuloplasty ring
Device: Simplici T Partial flexible mitral annuloplasty ring
Mitral valve Annuloplasty Ring repair using a Carpentier Edwards Physio 2 Complete flexible mitral ring
Mitral valve Annuloplasty Ring repair using a Simplici T Partial flexible mitral annuloplasty ring
Mean mitral valve gradient
Mean mitral valve gradient measured by transthoracic echocardiogram
Time frame: 1 year
Left ventricular remodelling
Assessment of left ventricular remodelling obtained from transthoracic echocardiography performed pre-operatively and at 1 year post surgery using 3D LV end-diastolic volume and 3D end-systolic volume measurements and 3D LV ejection fraction
Time frame: 1 year
Aortic-mitral coupling
3D transesophageal echocardiogram assessment intra-operatively both pre and post bypass assessing the entire mitral valvular and subvalvular apparatus, the left ventricle and the aortic valve to assess aortic-mitral valvular coupling and to determine whether there is a difference observed in aorto-mitral coupling between complete and partial ring repairs
Time frame: 1 year
Change in functional capacity
Functional capacity will be specifically assessed using workload achieved on stress transthoracic echocardiogram studies performed pre surgery and at 1 year post surgery. Measurements acquired will include total exercise time and total workload achieved. Also patients will complete SF-36 questionnaires pre-surgery and at 1 year post surgery for further assessment of change in functional capacity
Time frame: 1 year
No study locations are listed for this record.
Plan to share: No
No publications or documents are linked to this record.
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University Health Network, Toronto