Comparing Carillon Mitral Contour System with Guideline Directed Heart Failure for functional mitral regurgitation
Official title: The EMPOWER Trial - The Carillon Mitral Contour System® in Treating Heart Failure With FMR
Assessment of the Carillon Mitral Contour System® in Treating Heart Failure With Functional Mitral Regurgitation
- 2 groups
- Sites in Edmonton, Winnipeg and 1 more city
- Recruiting
Interventions
- Medical device
Carillon Mitral Contour System
The Carillon implant is designed to be deployed, tensioned, and locked in the coronary vein in order to reshape the mitral annulus and thus reduce mitral annular dilation and mitral regurgitation.
- Other intervention
Guideline Directed Heart Failure Medication
Heart failure medication per ACC/AHA guidelines
Canadian Sites (4)
3 of 4 recruiting
- Recruiting
St Boniface Hospital - University of Manitoba
Winnipeg, Manitoba
- Recruiting
Toronto General Hospital
Toronto, Ontario
- Recruiting
Unity Health Toronto, St Michael's Hospital
Toronto, Ontario
- Withdrawn
University of Alberta
Edmonton, Alberta
Eligibility Criteria
See who this study is looking for20 criteria
The trial’s own eligibility text, word for word from the registry. Only the trial site can say who takes part.
Inclusion
- +Age ≥ 18 years old
- +Symptomatic heart failure with functional (secondary) mitral regurgitation of at least 1+ (mild) severity
- +NYHA II, III, or IV
- +Six Minute Walk distance ≥ 100 meters and ≤ 600 meters
- +Left Ventricular Ejection Fraction ≤ 50%
- +≥ 55 mm (women)
- +≥ 57 mm (men)
- +LVESD ≤ 75 mm
- +Corrected NT-proBNP \> 1200 pg/ml measured within 60 days of randomizationRandomisedWhich group you go into is decided by chance, not by you or your doctor.Read more →, and/or one or more heart failure hospitalizations within one year prior to consentInformed consentThe process of being told what taking part involves, then choosing freely.Read more → or one or more outpatient visits for intensification of heart failure therapy within one year prior to consent.
- +Optimal Guideline directed heart failure medical therapy assessed by the Central Review Committee
- +Carillon implant can be sized and placed in accordance with the IFU
- +The subject has been informed of the nature of the trial and agrees to its provisions, including the possibility of randomization to the Control groupControl groupThe group a new treatment is measured against.Read more → and returning for all required post-procedure follow-upFollow-upContinued check-ins after the treatment part is finished.Read more → visits, and has provided written informed consent
Exclusion
- −Presence of a mechanical or bio-prosthetic mitral valve or, mitral valve annuloplasty, or leaflet repair device
- −Significant organic mitral valve pathology (e.g., moderate or severe myxomatous degeneration, with or without mitral leaflet prolapse, rheumatic disease, full or partial chordal rupture)
- −Severe tricuspid regurgitation associated with right ventricular dysfunction and enlargement
- −Severe mitral annular calcification
- −Severe aortic stenosis
- −Chronic, severe, medical conditions or pathology, other than heart failure, that will prevent likely survival beyond twelve (12) months or any other medical condition that, in the judgement of the InvestigatorPrincipal investigatorThe doctor or researcher responsible for running the study at a site.Read more → or Central Review Committee, makes the patient a poor candidate for this study
- −An entire list of eligibilityEligibility criteriaThe full list of requirements for taking part in a study.Read more → is available in the clinical investigational plan
- −Expected to require any cardiac surgery, including surgery for coronary artery disease (CAD) or valve disease within one (1) year
In plain language
Assembled directly from this trial’s registry record. Every sentence traces to a field below — nothing here is generated or interpreted.
What this study is
This study is testing a treatment for a condition.
This study is not organised into the usual phase numbers — that is common for device, behavioural, and diagnostic research.
From the trial registry
Built from these fields:
- designModule.designInfo.primaryPurpose
- designModule.phases
Who receives what
There are 2 groups in this study.
Group A receives one or more of: Carillon Mitral Contour System and Guideline Directed Heart Failure Medication.
Registry label: A: Intervention Group
Group B, the comparison group, receives Guideline Directed Heart Failure Medication.
Registry label: B: Control Group
From the trial registry
Built from these fields:
- armsInterventionsModule.armGroups[].label
- armsInterventionsModule.armGroups[].type
- armsInterventionsModule.armGroups[].interventionNames
How the study is run
Which group you would be placed in is decided by chance, like a coin flip — not by you and not by your doctor.
Neither you nor the study team would know which group you are in until the study ends.
From the trial registry
Built from these fields:
- designModule.designInfo.allocation
- designModule.designInfo.maskingInfo.masking
Is there a placebo?
This study does not list a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → group.
One group receives an existing treatment, so the two can be compared.
From the trial registry
Built from these fields:
- armsInterventionsModule.armGroups[].type
- armsInterventionsModule.armGroups[].interventionNames
Who the study is looking for
The study lists a minimum age of 18 years, with no upper limit given.
The study is open to people of any sex.
The study does not accept healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more →.
These are the criteria the study lists. Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part.
From the trial registry
Built from these fields:
- eligibilityModule.minimumAge
- eligibilityModule.sex
- eligibilityModule.healthyVolunteers
How big and how long
The study aims to enrol about 300 people.
The study is currently expected to finish around December 2030.
The main measurement is taken over: 12 months.
From the trial registry
Built from these fields:
- designModule.enrollmentInfo.count
- statusModule.completionDateStruct.date
- outcomesModule.primaryOutcomes[].timeFrame
What the study measures
Primary Safety Objective - Freedom from Major Adverse EventsAdverse eventAny medical problem that happens during a study, whether or not the treatment caused it.Read more → — measured over 12 months.
Primary Efficacy Objective 1 - Hierarchical Clinical Composite — measured over 24 months.
From the trial registry
Built from these fields:
- outcomesModule.primaryOutcomes[].measure
- outcomesModule.primaryOutcomes[].timeFrame
Source: NCT03142152 on ClinicalTrials.gov. The full registry text is further down this page — this summary never replaces it.
Not medical advice. What do these terms mean?
What is being tested — in plain terms
About Carillon Mitral Contour SystemDevice
The Carillon implant is designed to be deployed, tensioned, and locked in the coronary vein in order to reshape the mitral annulus and thus reduce mitral annular dilation and mitral regurgitation.
From the trial registry — its own words, unedited.
What a device is here: A physical instrument, implant, app or piece of equipment being studied.
Read the full explanation → · in clinical review
About Guideline Directed Heart Failure MedicationOther
Heart failure medication per ACC/AHA guidelines
From the trial registry — its own words, unedited.
What a other is here: An intervention the registry did not place in another category.
Read the full explanation → · in clinical review
Common questions
Answered from this trial’s registry record. Where the record doesn’t say, these answers say so rather than filling the gap.
Am I eligible for this trial?
Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part. Concord cannot make that determination, and neither can any tool that has not examined you.
What the study lists: a minimum age of 18 years.
The full inclusionInclusion criteriaThe things you must have or be for a study to consider you.Read more → and exclusion criteriaExclusion criteriaThe things that would prevent someone from taking part.Read more → are published on this page, exactly as the study team wrote them.
The useful next step is to bring this trial to your doctor. Answering a few questions first gives them something concrete to review.
From the trial registry
- eligibilityModule.minimumAge
- eligibilityModule.eligibilityCriteria
Is there a placebo?
This study does not list a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → group.
One group receives an existing treatment so the two can be compared.
From the trial registry
- armsInterventionsModule.armGroups[].type
Would I know which treatment I am getting?
Neither you nor the study team would know which group you are in until the study ends.
Which group you would be placed in is decided by chance, like a coin flip — not by you and not by your doctor.
From the trial registry
- designModule.designInfo.maskingInfo.masking
- designModule.designInfo.allocation
Who can join?
The study lists a minimum age of 18 years, with no upper limit given.
It is open to people of any sex.
It does not accept healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more →.
Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can confirm whether a particular person can take part.
From the trial registry
- eligibilityModule.minimumAge
- eligibilityModule.sex
- eligibilityModule.healthyVolunteers
How long would this take?
The study's main measurement is taken over: 12 months.
The study as a whole is currently expected to finish around 2030-12-31.
How long any one person takes part can differ from the study length. The study team can tell you what the schedule looks like in practice.
From the trial registry
- outcomesModule.primaryOutcomes[].timeFrame
- statusModule.completionDateStruct.date
How many people are taking part?
The study aims to enrol about 300 people.
From the trial registry
- designModule.enrollmentInfo.count
Where is this happening?
This study lists 12 locations, including: Edmonton, Alberta, Canada; Winnipeg, Manitoba, Canada; Toronto, Ontario, Canada; Ann Arbor, Michigan, United States; Royal Oak, Michigan, United States; Saginaw, Michigan, United States, and 6 more.
Sites can open and close during a study, so confirm with the team before travelling.
From the trial registry
- trial_locations
About This Trial
The objective of this prospective, randomized, double- blinded (patient and assessors), sham-controlled clinical trial is to assess the safety and efficacy of the CMCS in treating heart failure with functional regurgitation (FMR).
Other Sites (9)
University of Michigan
Ann Arbor, Michigan, United States
William Beaumont Hospital
Royal Oak, Michigan, United States
Ascension St. Marys Research Institute
Saginaw, Michigan, United States
CentraCare Heart and Vascular
Saint Cloud, Minnesota, United States
Albany Medical College,
Albany, New York, United States
University at Buffalo
Buffalo, New York, United States
Northwell Staten Island
New York, New York, United States
Vassar Brothers- Hudson Valley Cardiovascular Practice
Poughkeepsie, New York, United States
Rochester Regional Hospital
Rochester, New York, United States
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See if this trial could fit youThis page is for informational purposes only and does not constitute medical advice. Clinical trial eligibility can only be determined by the trial site after proper screening. Trial information is sourced from ClinicalTrials.gov and may not reflect the most current status. Always consult your healthcare provider before making decisions about clinical trial participation.