Mitral Annuloplasty Rings RCT

NCT03290872 | Unknown

• 1 other identifier: 14-7851
• Study Type: interventional
• Target: 50
• Locations: 0 countries
• Sites: N/A

Brief 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

Outcome Measures

Primary Outcomes (1)

• Mean mitral valve gradient

  Mean mitral valve gradient measured by transthoracic echocardiogram

  1 year

Secondary Outcomes (3)

• Left ventricular remodelling

  1 year

• Aortic-mitral coupling

  1 year

• Change in functional capacity

  1 year

Study Arms (2)

Carpentier Edwards Physio 2 Complete flexible mitral ring

ACTIVE COMPARATOR

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

Device: Carpentier Edwards Physio 2 Complete flexible mitral ring

Simplici T Partial flexible mitral annuloplasty ring

ACTIVE COMPARATOR

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

Device: Simplici T Partial flexible mitral annuloplasty ring

Interventions

Carpentier Edwards Physio 2 Complete flexible mitral ring DEVICE

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

Carpentier Edwards Physio 2 Complete flexible mitral ring

Simplici T Partial flexible mitral annuloplasty ring DEVICE

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

Simplici T Partial flexible mitral annuloplasty ring

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University Health Network, Toronto: lead

Study Officials

• Wendy W Tsang, MD

  University Health Network, Toronto General Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Wendy W Tsang, MD

CONTACT

4163403155; Wendy.Tsang@uhn.ca

Kate H Rankin, MBBS

CONTACT

4163403155; kate.rankin@uhn.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 18, 2017
• First Posted: September 25, 2017
• Study Start: September 1, 2017
• Primary Completion: September 1, 2019
• Study Completion: September 1, 2019
• Last Updated: September 25, 2017

Record last verified: 2017-09

Data Sharing

• IPD Sharing: Will not share