Carillon Device for Heart Failure with Mitral Regurgitation

Recruiting at 97 trial locations

Overseen By John Vavalle, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Cardiac Dimensions, Inc.

Must be taking: Heart failure medications

Disqualifiers: Mitral valve pathology, Aortic stenosis, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 11

Duration: 1 day

300 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new device called the Carillon Mitral Contour System to determine its safety and effectiveness for people with heart failure and functional mitral regurgitation (when the heart valve doesn't close tightly). Participants will receive either the new device with standard heart failure medication or just the standard medication to compare outcomes. This trial may suit individuals who experience noticeable heart failure symptoms, have been diagnosed with mild to severe mitral valve leakage, and can walk between 100 and 600 meters in six minutes. As an unphased trial, it offers participants the chance to contribute to groundbreaking research that could lead to new treatment options for heart failure.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, it mentions that participants should be on a guideline-directed heart failure medication regimen, which suggests you may need to continue certain heart medications.

What prior data suggests that the Carillon Device is safe for treating heart failure with mitral regurgitation?

Research has shown that the Carillon Mitral Contour System is generally well-tolerated by patients. Studies have found that this device often leads to positive changes in the heart's structure, helping to reduce the severity of functional mitral regurgitation—a condition where the heart's mitral valve doesn't close properly.

In terms of safety, the device has been used worldwide, and many patients have experienced improvements in their quality of life without major issues. Although the studies do not list specific side effects, the positive results suggest that the treatment is relatively safe. However, as with any medical treatment, discussing potential risks with a doctor is important. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatment?

The Carillon Mitral Contour System is unique because it offers a mechanical solution to address mitral regurgitation in heart failure patients, unlike standard treatments that primarily rely on medications like ACE inhibitors, beta-blockers, or diuretics. This device works by reshaping the mitral valve to reduce leakage, which can help improve heart function and alleviate symptoms. Researchers are excited about this treatment because it targets the structural cause of the problem directly, potentially providing relief for patients who might not respond well to medications alone. Plus, it could offer a less invasive alternative to surgical interventions.

What evidence suggests that the Carillon Mitral Contour System is effective for heart failure with mitral regurgitation?

Research has shown that the Carillon Mitral Contour System can assist people with heart failure and functional mitral regurgitation (FMR). In this trial, participants in the intervention group will receive the Carillon Mitral Contour System along with guideline-directed heart failure medication. Studies have indicated that patients using this device reported improved quality of life and a noticeable decrease in FMR severity. International research found positive changes in heart structure, specifically in the left side of the heart. Overall, these findings suggest that the Carillon device could be a helpful treatment for managing heart failure with FMR. ^{1 2 3 4 6}

Who Is on the Research Team?

Samir Kapadia

Principal Investigator

The Cleveland Clinic

Randall Starling, MD

Principal Investigator

The Cleveland Clinic

Are You a Good Fit for This Trial?

This trial is for adults with heart failure and mild to severe functional mitral regurgitation who can walk a bit but not too far, have reduced heart pumping function, and are on standard heart failure meds. Not eligible if they need certain other heart treatments or have specific valve issues or devices already in place.

Inclusion Criteria

I have been diagnosed with a type of heart muscle disease.

I have mild to moderate heart valve leakage and surgery isn't needed within a year.

My heart condition limits my physical activity.

Exclusion Criteria

I do not have severe health issues, other than heart failure, that would limit my life to under a year.

I need or will need a special heart therapy within the next year.

I have a serious mitral valve condition as confirmed by a specialist.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Randomization and Baseline Assessment

Eligible subjects undergo baseline assessments including echocardiographic examination, coronary angiogram, and venogram before randomization

1-2 weeks

1 visit (in-person)

Treatment

Subjects in the Intervention group undergo the Carillon implant procedure, while Control group subjects undergo a similar index procedure without device placement

1 day

1 visit (in-person)

Follow-up

Subjects are evaluated at 1, 6, 12, 18, and 24 months post-randomization to assess long-term safety and functional status

24 months

5 visits (in-person)

Long-term Follow-up

After unblinding at 24 months, all subjects are followed with annual contact and echocardiogram for an additional three years

3 years

3 visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Carillon Mitral Contour System

Trial Overview The EMPOWER Trial is testing the Carillon Mitral Contour System's safety and effectiveness against standard medications for treating heart failure caused by leaky mitral valves. Participants will be randomly assigned to receive either the device or continue with their usual medication.

How Is the Trial Designed?

Group I: Intervention Group Experimental Treatment 2 Interventions

Carillon Mitral Contour System and Guideline Directed Heart Failure Medication

Group II: Control Group Active Control 1 Intervention

Guideline Directed Heart Failure Medication

Carillon Mitral Contour System is already approved in European Union, United States for the following indications:

Approved in European Union as Carillon Mitral Contour System for:

• Functional mitral regurgitation (FMR) in heart failure patients

Approved in United States as Carillon Mitral Contour System for:

• Investigational use only; not yet approved for commercial use

Who Is Running the Clinical Trial?

Cardiac Dimensions, Inc.

Lead Sponsor

Trials

2

Recruited

550+

Published Research Related to This Trial

The Carillon Mitral Contour System significantly improved quality of life and functional capacity in heart failure patients with functional mitral regurgitation, as evidenced by increased 6-minute walk test distances and Kansas City Cardiomyopathy Questionnaire scores at both 1 and 12 months post-implantation.

In a meta-analysis of 139 patients, over 60% reported meaningful improvements in quality of life, and nearly 68% experienced a reduction in heart failure severity (NYHA class) within the first month, indicating the device's efficacy in managing symptoms of heart failure.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of Carillon Mitral Contour System on patient-reported outcomes in functional mitral regurgitation: an individual participant data meta-analysis. Khan, MS., Friede, T., Anker, SD., et al.[2021]

The Carillon Mitral Contour System is a minimally invasive catheter-based procedure that effectively reduces functional mitral valve regurgitation by converging the valve leaflets using a nitinol clip implanted in the coronary sinus.

The procedure is performed under fluoroscopy and is verified for success through transesophageal echocardiography, ensuring that it does not impair coronary vessel perfusion, allowing for additional cardiac therapies like resynchronization therapy to be performed afterward.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Percutaneous mitral valve annuloplasty with the carillon mitral contour system by cardiac dimensions. A minimally invasive therapeutic option for the treatment of severe functional mitral valve regurgitation]. Degen, H., Lickfeld, T., Stoepel, C., et al.[2021]

The modified Carillon® Mitral Contour System® was safely implanted in 36 patients with congestive heart failure and significant functional mitral regurgitation, with only one unrelated major adverse event occurring within 30 days.

Patients showed significant reductions in mitral regurgitation and improvements in functional capacity, such as better performance on 6-minute walk tests, indicating the device's efficacy in treating FMR without the previously observed issue of anchor fractures.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Coronary sinus-based percutaneous annuloplasty as treatment for functional mitral regurgitation: the TITAN II trial. Lipiecki, J., Siminiak, T., Sievert, H., et al.[2021]

The CARILLON® mitral contour system significantly reduces mitral regurgitation (MR) severity and left atrial (LA) volume in heart failure patients, as shown in a meta-analysis of 209 participants from three studies, with a notable decrease in MR volume and grade.

Patients treated with the CARILLON® device experienced improved functional status, reflected by a better New York Heart Association class and a lower rate of heart failure hospitalizations compared to controls, indicating its potential to enhance quality of life and reduce hospital visits.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Individual patient data meta-analysis of the effects of the CARILLON® mitral contour system. Giallauria, F., Di Lorenzo, A., Parlato, A., et al.[2021]

The Carillon Mitral Contour System was evaluated in a real-world setting with 101 patients, showing significant reductions in mitral regurgitation and improvements in heart failure symptoms over 5 years, similar to results from controlled trials.

Despite a 40.1% all-cause mortality rate and a 53.9% incidence of heart failure hospitalizations, the therapy demonstrated a favorable safety profile and potential benefits for patients with functional mitral regurgitation, including those previously excluded from clinical trials.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The CINCH-FMR postmarket registry: Real-world long-term outcomes with percutaneous mitral valve repair with the Carillon Mitral Contour System®. Yildiz, M., Haude, M., Sievert, H., et al.[2023]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8120406/

Effect of Carillon Mitral Contour System on patient‐reported ... The Carillon Mitral Contour System significantly improved patient‐reported quality‐of‐life outcomes in heart failure patients with functional mitral ...

2. tctmd.com tctmd.com/news/positive-results-carillon-mitral-device-seen-real-world-registries

Positive Results With Carillon Mitral Device Seen in Real- ... There seem to be benefits that you can measure with echo, such as reduction in the severity of functional mitral regurgitation. And there seem ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT02325830

Carillon Mitral Contour System® for Reducing Functional ... The objective of this prospective, multi-center, randomized, double-blind trial is to assess the safety and efficacy of the Carillon Mitral Contour System ...

4. cardiacdimensions.com cardiacdimensions.com/physicians/

Carillon Mitral Contour System International studies have shown that patients treated with the Carillon therapy often experience positive left ventricular remodeling and have favorable long- ...

5. sciencedirect.com sciencedirect.com/science/article/abs/pii/S155383892300828X

The CINCH-FMR postmarket registry: Real-world long-term ... The Carillon® Mitral Contour System® has been studied in 4 prospective controlled studies in the treatment of functional mitral regurgitation (FMR) where it ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7754746/

Individual patient data meta‐analysis of the effects of the ... This comprehensive meta‐analysis of individual patient data has shown that CARILLON® device provides statistically significant and clinically meaningful ...