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Mitral Annuloplasty Rings RCT

NCT ID: NCT03290872

Last Updated: 2017-09-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-09-30

Study Completion Date

2019-09-30

Brief Summary

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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.

Detailed Description

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Conditions

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Degenerative Mitral Valve Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Carpentier Edwards Physio 2 Complete flexible mitral ring

Mitral Valve Annuloplasty Ring Repair using Carpentier Edwards Physio 2 Complete flexible mitral ring

Group Type ACTIVE_COMPARATOR

Carpentier Edwards Physio 2 Complete flexible mitral ring

Intervention Type DEVICE

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

Simplici T Partial flexible mitral annuloplasty ring

Mitral Valve Annuloplasty Ring Repair using Simplici T Partial flexible mitral annuloplasty ring

Group Type ACTIVE_COMPARATOR

Simplici T Partial flexible mitral annuloplasty ring

Intervention Type DEVICE

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

Interventions

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Carpentier Edwards Physio 2 Complete flexible mitral ring

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

Intervention Type DEVICE

Simplici T Partial flexible mitral annuloplasty ring

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

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Mitral regurgitation secondary to degenerative valve disease referred to Prof Tirone David (Co-investigator) will be invited to take part.
* The mitral valve anatomy must be anatomy suitable for repair.
* The patient must be able to perform treadmill exercise echocardiography.
* The patient must be over 18 years of age.

Exclusion Criteria

* Any presence of life-limiting disease process, for example advanced malignancy.
* Hemodynamically unstable patients in cardiogenic shock
* Concomitant aortic valve disease/surgery
* Previous mitral valve repair
* Impaired left ventricular systolic function as defined by a left ventricular ejection fraction of ≤ 50%.
* If the patient lives out of state or cannot attend follow up visits.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Health Network, Toronto

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Wendy W Tsang, MD

Role: PRINCIPAL_INVESTIGATOR

University Health Network, Toronto General Hospital

Central Contacts

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Wendy W Tsang, MD

Role: CONTACT

[email protected]
4163403155

Kate H Rankin, MBBS

Role: CONTACT

[email protected]
4163403155

Other Identifiers

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14-7851

Identifier Type: -

Identifier Source: org_study_id