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Mitral Annuloplasty Rings RCT

NCT03290872 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2017-09-25

No results posted yet for this study

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.

Conditions

  • Degenerative Mitral Valve Disease

Interventions

DEVICE

Carpentier Edwards Physio 2 Complete flexible mitral ring

Mitral valve Annuloplasty Ring repair using a Carpentier Edwards Physio 2 Complete flexible mitral ring

DEVICE

Simplici T Partial flexible mitral annuloplasty ring

Mitral valve Annuloplasty Ring repair using a Simplici T Partial flexible mitral annuloplasty ring

Sponsors & Collaborators

  • University Health Network, Toronto

    lead OTHER

Principal Investigators

  • Wendy W Tsang, MD · University Health Network, Toronto General Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-09-30
Primary Completion
2019-09-30
Completion
2019-09-30

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03290872 on ClinicalTrials.gov