What is the mechanism of action of this treatment?

Common treatments for heart valve disease, particularly for mitral regurgitation, include mechanical reshaping techniques such as the Carillon Mitral Contour System. This system works by implanting a device that reshapes the mitral annulus, thereby reducing the backflow of blood (regurgitation) into the left atrium. This mechanical intervention is crucial as it directly addresses the structural issues causing the regurgitation, leading to improved heart function and reduced symptoms. For patients, this means a potential reduction in heart failure symptoms, improved quality of life, and possibly a decreased need for more invasive surgical procedures.

What side effects are associated with this type of intervention?

Common treatments for heart valve disease, particularly those involving mechanical reshaping of the mitral annulus like the Carillon Mitral Contour System, include surgical and percutaneous mitral valve repair. Known side effects of these treatments can include bleeding, infection, thromboembolic events, arrhythmias, and device-related complications such as device migration or malfunction. Additionally, patients may experience heart failure symptoms if the procedure is not fully successful in reducing mitral regurgitation.

What prior FDA approvals exist?

The FDA has approved several treatments for heart valve disease, particularly for mitral regurgitation. One notable device is the MitraClip, which is used for transcatheter mitral valve repair by clipping together a portion of the mitral valve leaflets to reduce regurgitation. This device is similar in purpose to the Carillon Mitral Contour System, which mechanically reshapes the mitral annulus. Other treatments include surgical valve repair or replacement, and medications such as diuretics, beta-blockers, and ACE inhibitors to manage symptoms and underlying conditions. These treatments aim to improve valve function and patient outcomes.

What other types of research exist?

Promising novel alternatives to the Carillon Mitral Contour System for treating heart valve disease include: 1) Transcatheter Mitral Valve Repair (TMVR) devices such as MitraClip, which use a minimally invasive approach to clip the mitral valve leaflets together, reducing regurgitation. 2) Transcatheter Mitral Valve Replacement (TMVR) devices like Tendyne and Intrepid, which replace the mitral valve via catheter-based techniques. 3) Percutaneous annuloplasty devices such as Cardioband, which adjust the size of the mitral annulus through a catheter-based approach. These alternatives offer less invasive options with promising outcomes for patients with mitral regurgitation.

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Device

Carillon Device for Heart Failure with Mitral Regurgitation

N/A

Recruiting

Led By Marc Gillinov, MD

Research Sponsored by Cardiac Dimensions, Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Diagnosis of ischemic or non-ischemic cardiomyopathy

NYHA Class II, III, or IV

Must not have

Chronic, severe, medical conditions or pathology, other than heart failure, that will prevent likely survival beyond twelve (12) months

Class I indication for cardiac resynchronization therapy (CRT), or anticipated need for CRT within twelve (12) months

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 12 months of follow-up, and any available data up to 24 months

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a device called the Carillon Mitral Contour System, which helps the mitral valve in the heart work better. It targets patients with heart failure and a specific valve problem. The device reshapes the valve to improve its function and reduce symptoms.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Potential side effects of the Carillon system may include complications related to implanting a device in the heart, such as bleeding, infection, or damage to nearby structures. Standard medications' side effects vary but often include dizziness, fatigue, and changes in blood pressure.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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

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My heart condition limits my physical activity.

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I can walk between 150 and 450 meters in six minutes.

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My heart's pumping ability is reduced.

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My heart failure markers are high or I've been hospitalized for heart failure recently.

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I am on a heart failure medication plan as per guidelines.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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

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

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

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My heart's right side is not working well and is enlarged.

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I have severe hardening of the heart's mitral valve ring.

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I have a severe narrowing of my heart's aortic valve.

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I am not expected to need heart surgery within the next year.

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I have a clot in my heart's left atrial appendage or a device to close it.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12 months of follow-up, and any available data up to 24 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~12 months of follow-up, and any available data up to 24 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 months of follow-up, and any available data up to 24 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Primary Efficacy Objective 1 - Hierarchical Clinical Composite

Primary Safety Objective - Freedom from Major Adverse Events

Secondary study objectives

Secondary Efficacy Objective 1- Regurgitant Volume

Secondary Efficacy Objective 2 - Change in LV End-diastolic Volume

Secondary Efficacy Objective 3 - Change in LV End-Systolic Volume

+7 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Intervention GroupExperimental Treatment2 Interventions

Carillon Mitral Contour System and Guideline Directed Heart Failure Medication

Group II: Control GroupActive Control1 Intervention

Guideline Directed Heart Failure Medication

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Carillon Mitral Contour System

2015

N/A

~170

0 / 14Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for heart valve disease, particularly for mitral regurgitation, include mechanical reshaping techniques such as the Carillon Mitral Contour System. This system works by implanting a device that reshapes the mitral annulus, thereby reducing the backflow of blood (regurgitation) into the left atrium. This mechanical intervention is crucial as it directly addresses the structural issues causing the regurgitation, leading to improved heart function and reduced symptoms. For patients, this means a potential reduction in heart failure symptoms, improved quality of life, and possibly a decreased need for more invasive surgical procedures.

MitraClip Therapy for Mitral Regurgitation: Secondary Mitral Regurgitation.