At a glance
- What the study gets you
- Access to the study treatment being tested
- Type of study
- Interventional (receives a drug or procedure)
- Time in hospital
- In-person visits at study sites — visit count not specified by the sponsor
- Drug or intervention
- Carillon Mitral Contour System (device), Guideline Directed Heart Failure Medication (other)
- How long the study runs
- Study runs about 155 months (dates as stated)
- About the drug or intervention
- Carillon Mitral Contour System — device: 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. · Guideline Directed Heart Failure Medication — other: Heart failure medication per ACC/AHA guidelines
- Patient visit burden
- Not specified by the sponsor
In plain English
The EMPOWER Trial is testing a device called the Carillon Mitral Contour System in people with heart failure and functional mitral regurgitation, which is when the heart's mitral valve does not close properly because the heart is weakened. The trial is funded by Cardiac Dimensions, Inc.
Who can take part
- Age 18 or over
- Symptomatic heart failure with functional (secondary) mitral regurgitation of at least mild severity
- Heart failure symptoms rated as New York Heart Association (NYHA) class II, III or IV
- Can walk between 100 and 600 metres in a six-minute walk test
- Heart pumping strength (left ventricular ejection fraction) of 50% or less
- Heart chamber size within set limits measured by scan
- A blood test marker for heart strain (NT-proBNP) above a set level within 60 days, and/or a hospital stay or extra outpatient visit for heart failure treatment within the past year
- Already on the best standard heart failure medicines, as checked by the study team
- The Carillon device can be fitted in the right size and position
- Willing and able to give informed consent, accept possible placement in the control group, and attend all follow-up visits
Who may not be able to
- Already has an artificial (mechanical or tissue) mitral valve, a repaired mitral valve ring, or a leaflet repair device
- Has significant damage to the mitral valve itself, such as severe wear, rheumatic disease, or a torn supporting cord
- Has severe leakage of the tricuspid valve with a weak or enlarged right side of the heart
- Has severe calcium deposits around the mitral valve
- Has severe narrowing of the aortic valve
- Is expected to need heart surgery, including for coronary artery disease or valve disease, within one year
- Has another serious long-term illness, apart from heart failure, that is likely to limit life beyond twelve months, or any other condition that makes them unsuitable in the view of the study team
What taking part involves
- • Being randomly placed (by chance) into either the group that receives the Carillon device or a control group that does not
- • Having the Carillon device implanted, if placed in the treatment group
- • Attending all required follow-up visits after the procedure
Time commitment: Not stated — ask the trial team
Plain-English summary (AI-generated) from registry data. Not eligibility advice — only the trial team can confirm whether you can take part. Use the eligibility checker to see how your health profile matches this trial.
- Type of study
- Testing a treatment
- Ages
- 18 Years and over
- Who
- All
- Number of participants
- 300
- Started
- 2018-01-01
- Last checked
- 2026-04
Plain English Summary
What is this study?
- • Testing a new treatment for functional mitral regurgitation
- • NA - 300 participants
- • 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)
Who can take part?
- • Ages 18 Years and over
- • Diagnosed with functional mitral regurgitation
Where?
- • Leeds - St James University Hospital
This is a simplified summary. Always discuss with your doctor before making any decisions.
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).
More detail
A total of 300 subjects will be randomized at up to 100 investigational sites in the United States, Canada, and Europe. Subjects will be randomized into one of two study groups using a 1:1 (Intervention : Control) ratio. Study subjects who are eligible for this clinical study will undergo a transthoracic echocardiographic examination prior to randomization to evaluate the inclusion criteria associated with the severity of mitral regurgitation. A coronary angiogram will be performed to evaluate the coronary artery anatomy and a venogram to assess the suitability of the coronary sinus/great cardiac vein (CS/GCV) for placement of the Carillon implant. If the subject meets the anatomic requirements for the Carillon implant placement, the subject will be randomized. Subjects who meet all eligibility criteria will be randomized into one of two study groups (Intervention or Control). Subjects randomized to the Intervention group will undergo the Carillon implant procedure. Subjects randomized to the Control group will experience an index procedure similar to the Intervention group (without implant placement) to ensure they will not be able to deduce the group assignment based on the type of intervention or time associated with the procedure. After the study subjects are discharged, the subjects' primary care specialists (cardiologist/heart failure physician) and clinical investigation site staff will coordinate follow-up evaluations. Subjects will be evaluated at one (1), six (6), twelve (12), eighteen (18) and twenty-four (24) months post-randomization, to assess long-term safety, and functional and clinical status. After the 24-month evaluation, all subjects will be unblinded. All Intervention and Control subjects will be followed with an abbreviated annual contact and echocardiogram for an additional three (3) years, for a total of five (5) years.
How this trial compares with your answers
Answer 2 more questions to improve match
What we know so far
Still need:
- • Tell us your age for better matching
- • Tell us your sex for better matching
Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.
Eligibility at a Glance
Key info
- Age: 18 Years and over
- Who can join: All genders
Treatment history
Treatments you must have had:
- ✓ post-procedure follow-up visits, and has provided written informed consent
What the study is looking for
- ✓causing symptoms 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%
- ✓LVEDD:
Who cannot take part
- ✗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...
- ✗Severe tricuspid regurgitation associated with right ventricular dysfunction and enlargement
- ✗Severe mitral annular calcification
- ✗Severe aortic stenosis
See the full criteria
Where Is This Study? (1 UK site)
St James University Hospital
Leeds, United Kingdom
How to Get in Touch
Hank Hauser
Sponsor contactCONTACT