Mitral Annuloplasty Rings RCT

A Study to Assess the Effects of Two Commonly Used Mitral Valve Annuloplasty Rings in Mitral Valve Repair on Short-term Outcomes.

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.

Study Overview

• Status: Unknown
• Conditions: Degenerative Mitral Valve Disease
• Intervention / Treatment: Device: Carpentier Edwards Physio 2 Complete flexible mitral ring; Device: Simplici T Partial flexible mitral annuloplasty ring

• Study Type: Interventional
• Enrollment (Anticipated): 50
• Phase: Not Applicable

Contacts and Locations

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Carpentier Edwards Physio 2 Complete flexible mitral ring; 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 a Carpentier Edwards Physio 2 Complete flexible mitral ring
Active Comparator: Simplici T Partial flexible mitral annuloplasty 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 Simplici T Partial flexible mitral annuloplasty ring

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean mitral valve gradient	Mean mitral valve gradient measured by transthoracic echocardiogram	1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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	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	1 year

Collaborators and Investigators

• Sponsor: University Health Network, Toronto
• Investigators: Principal Investigator: Wendy W Tsang, MD, University Health Network, Toronto General Hospital

Study record dates

Study Major Dates

• Study Start (Anticipated): September 1, 2017
• Primary Completion (Anticipated): September 1, 2019
• Study Completion (Anticipated): September 1, 2019

Study Registration Dates

• First Submitted: September 18, 2017
• First Submitted That Met QC Criteria: September 20, 2017
• First Posted (Actual): September 25, 2017

Study Record Updates

• Last Update Posted (Actual): September 25, 2017
• Last Update Submitted That Met QC Criteria: September 20, 2017
• Last Verified: September 1, 2017

More Information

Terms related to this study

• Other Study ID Numbers: 14-7851

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No