ClinicalTrials.gov
ClinicalTrials.gov Menu

Mitral Annuloplasty Rings RCT

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03290872
Recruitment Status : Not yet recruiting
First Posted : September 25, 2017
Last Update Posted : September 25, 2017
Sponsor:
Information provided by (Responsible Party):
University Health Network, Toronto

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.


Condition or disease Intervention/treatment Phase
Degenerative Mitral Valve Disease Device: Carpentier Edwards Physio 2 Complete flexible mitral ring Device: Simplici T Partial flexible mitral annuloplasty ring Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: A Study to Assess the Effects of Two Commonly Used Mitral Valve Annuloplasty Rings in Mitral Valve Repair on Short-term Outcomes.
Estimated Study Start Date : September 2017
Estimated Primary Completion Date : September 2019
Estimated Study Completion Date : September 2019

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




Primary Outcome Measures :
  1. Mean mitral valve gradient [ Time Frame: 1 year ]
    Mean mitral valve gradient measured by transthoracic echocardiogram


Secondary Outcome Measures :
  1. Left ventricular remodelling [ Time Frame: 1 year ]
    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

  2. Aortic-mitral coupling [ Time Frame: 1 year ]
    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

  3. Change in functional capacity [ Time Frame: 1 year ]
    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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03290872


Contacts
Contact: Wendy W Tsang, MD 4163403155 Wendy.Tsang@uhn.ca
Contact: Kate H Rankin, MBBS 4163403155 kate.rankin@uhn.ca

Sponsors and Collaborators
University Health Network, Toronto
Investigators
Principal Investigator: Wendy W Tsang, MD University Health Network, Toronto General Hospital

Responsible Party: University Health Network, Toronto
ClinicalTrials.gov Identifier: NCT03290872     History of Changes
Other Study ID Numbers: 14-7851
First Posted: September 25, 2017    Key Record Dates
Last Update Posted: September 25, 2017
Last Verified: September 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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