Degenerative Mitral Valve DiseaseNCT03290872
Mitral Annuloplasty Rings RCT
A study testing Carpentier Edwards Physio 2 Complete flexible mitral ring and Simplici T Partial flexible mitral annuloplasty ring in people with Degenerative Mitral Valve Disease, run by University Health Network, Toronto.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Degenerative Mitral Valve Disease
- What is being tested?
- Carpentier Edwards Physio 2 Complete flexible mitral ring and Simplici T Partial flexible mitral annuloplasty ring
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- Sep 2017to Sep 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: 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.
Read more
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
- Being tested
- Carpentier Edwards Physio 2 Complete flexible mitral ring, Simplici T Partial flexible mitral annuloplasty ring
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Carpentier Edwards Physio 2 Complete flexible mitral ringDevice
Mitral valve Annuloplasty Ring repair using a Carpentier Edwards Physio 2 Complete flexible mitral ring
Simplici T Partial flexible mitral annuloplasty ringDevice
Mitral valve Annuloplasty Ring repair using a Simplici T Partial flexible mitral annuloplasty ring
| Study group | Role | What they receive |
|---|---|---|
| Carpentier Edwards Physio 2 Complete flexible mitral ring | Active comparator | Mitral Valve Annuloplasty Ring Repair using Carpentier Edwards Physio 2 Complete flexible mitral ring Receives: 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 Receives: Device: Simplici T Partial flexible mitral annuloplasty ring |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean mitral valve gradient
Mean mitral valve gradient measured by transthoracic echocardiogram
Measured: 1 year
Secondary outcomes (3)
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
Measured: 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
Measured: 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
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2017
- Study startSep 2017 (estimated)
- Primary completionSep 2019 (estimated)
- Study completionSep 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Degenerative Mitral Valve DiseaseStudies of the same condition, open and under way.
- More trials run by University Health Network, TorontoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Health Network, Toronto
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Wendy W Tsang, MD, Principal investigator, University Health Network, Toronto General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03290872
- Sponsor's protocol ID
- 14-7851
- Status last verified
- Sep 2017
- First submitted
- 18 Sep 2017
- Last updated
- 25 Sep 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study to Assess the Effects of Two Commonly Used Mitral Valve Annuloplasty Rings in Mitral Valve Repair on Short-term Outcomes.
- ClinicalTrials.gov ID
- NCT03290872
- Acronym / sponsor ID
- 14-7851
- Conditions
- Degenerative Mitral Valve Disease
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- University Health Network, TorontoUniversity, hospital or other
- Study start
- Sep 2017 (estimated)
- Primary completion
- Sep 2019 (estimated)
- Study completion
- Sep 2019 (estimated)
- First posted
- 25 Sep 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Carpentier Edwards Physio 2 Complete flexible mitral ring | Active comparator | Device: Carpentier Edwards Physio 2 Complete flexible mitral ringMitral Valve Annuloplasty Ring Repair using Carpentier Edwards Physio 2 Complete flexible mitral ring |
| Simplici T Partial flexible mitral annuloplasty ring | Active comparator | Device: Simplici T Partial flexible mitral annuloplasty ringMitral Valve Annuloplasty Ring Repair using Simplici T Partial flexible mitral annuloplasty ring |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (6 listed)
- 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%.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Carpentier Edwards Physio 2 Complete flexible mitral ringMitral valve Annuloplasty Ring repair using a Carpentier Edwards Physio 2 Complete flexible mitral ring | Device | Carpentier Edwards Physio 2 Complete flexible mitral ring |
| Simplici T Partial flexible mitral annuloplasty ringMitral valve Annuloplasty Ring repair using a Simplici T Partial flexible mitral annuloplasty ring | Device | Simplici T Partial flexible mitral annuloplasty ring |
Primary outcome
Mean mitral valve gradient
Time frame: 1 year
Mean mitral valve gradient measured by transthoracic echocardiogram
3 secondary outcomes
Left ventricular remodelling
Time frame: 1 year
Aortic-mitral coupling
Time frame: 1 year
Change in functional capacity
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2017.
- Individual participant dataSharing planned: No
Related trials for Degenerative Mitral Valve Disease
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Anchord Mitral Chordal Repair System - FIH
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ATLAS (AltaValve) Pivotal Trial
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Clinical Trial to Evaluate the Safety and Effectiveness of Using the Tendyne Transcatheter Mitral Valve System for the Treatment of Symptomatic Mitral Regurgitation
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Edwards PASCAL CLASP IID/IIF Pivotal Clinical Trial
Degenerative Mitral Valve Disease, Mitral Regurgitation
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Wendy W Tsang, MD principal investigator
University Health Network, Toronto General Hospital
Questions about this trial
What is this clinical trial studying?
A study testing Carpentier Edwards Physio 2 Complete flexible mitral ring and Simplici T Partial flexible mitral annuloplasty ring in people with Degenerative Mitral Valve Disease, run by University Health Network, Toronto.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 25 Sep 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Wendy W Tsang, MD (4163403155, Wendy.Tsang@uhn.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean mitral valve gradient (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Sep 2017.