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Clinical Trial Summary

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.


Clinical Trial Description

n/a


Study Design


Related Conditions & MeSH terms

  • Degenerative Mitral Valve Disease

NCT number NCT03290872
Study type Interventional
Source University Health Network, Toronto
Contact Wendy W Tsang, MD
Phone 4163403155
Email Wendy.Tsang@uhn.ca
Status Not yet recruiting
Phase N/A
Start date September 2017
Completion date September 2019

See also
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Active, not recruiting NCT04281940 - Chordal Repair for Transcatheter Mitral Valve Repair (TMVr) N/A
Not yet recruiting NCT05417945 - A Prospective, Multicenter Study to Evaluate the JensClip Transcatheter Valve Repair System N/A
Recruiting NCT03433274 - Clinical Trial to Evaluate the Safety and Effectiveness of Using the Tendyne Transcatheter Mitral Valve System for the Treatment of Symptomatic Mitral Regurgitation N/A
Active, not recruiting NCT03674593 - Clinical and Fundamental Aspects of Prosthetics and Translocation of Mitral Valve Chordae N/A
Recruiting NCT05595226 - Effect of RT3D-TEE-guided Mitral Valve Repair on Outcomes in Patients With Degenerative Mitral Valve Disease N/A
Terminated NCT04666480 - Early Feasibility Study of the PLAR Implant and Delivery System to Treat Degenerative Mitral Regurgitation N/A