Mitral Annuloplasty Rings RCT

Degenerative Mitral Valve Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03290872
• Other study ID #: 14-7851
• Status: Not yet recruiting
• Phase: N/A
• First received: September 18, 2017
• Last updated: September 20, 2017
• Start date: September 2017
• Est. completion date: September 2019

Study information

• Verified date: September 2017
• Source: University Health Network, Toronto
• Contact: Wendy W Tsang, MD
• Phone: 4163403155
• Email: Wendy.Tsang[@]uhn.ca
• Is FDA regulated: No
• Study type: Interventional

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 50
• Est. completion date: September 2019
• Est. primary completion date: September 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Degenerative Mitral Valve Disease

Intervention

Device:
• Carpentier Edwards Physio 2 Complete flexible mitral ring
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 a Simplici T Partial flexible mitral annuloplasty ring

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University Health Network, Toronto

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean mitral valve gradient	Mean mitral valve gradient measured by transthoracic echocardiogram	1 year
Secondary	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
Secondary	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
Secondary	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