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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

Timeline

Screening 3 weeks

Treatment Varies

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

Awards & highlights

Study Summary

This trial will compare the safety and effectiveness of a new mitral valve device to treat heart failure with mild regurgitation to current standard care.

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.Check my eligibility

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.See study design

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.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Primary Efficacy Objective 1 - Hierarchical Clinical Composite

Primary Safety Objective - Freedom from Major Adverse Events

Secondary outcome measures

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

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

0 / 6Eligibility criteria met

Find a Location

Who is running the clinical trial?

Cardiac Dimensions, Inc.Lead Sponsor

1 Previous Clinical Trials

250 Total Patients Enrolled

Marc Gillinov, MDPrincipal InvestigatorThe Cleveland Clinic

5 Previous Clinical Trials

3,430 Total Patients Enrolled

Samir Kapadia, MDPrincipal InvestigatorThe Cleveland Clinic

3 Previous Clinical Trials

3,712 Total Patients Enrolled

Media Library

Carillon Mitral Contour System (Device) Clinical Trial Eligibility Overview. Trial Name: NCT03142152 — N/A

Heart Valve Disease Research Study Groups: Intervention Group, Control Group

Heart Valve Disease Clinical Trial 2023: Carillon Mitral Contour System Highlights & Side Effects. Trial Name: NCT03142152 — N/A

Carillon Mitral Contour System (Device) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03142152 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the estimated number of participants in this trial?

"Cardiac Dimensions, Inc. is in search of 300 individuals that fit the trial's entrance requirements to conduct this study at Banner University Tucson and University of California- San Francisco."

Answered by AI

How many venues are participating in the experimental protocol?

"This clinical trial is available in 40 various medical locations, including Banner University Tuscon (Tuscon), University of California- San Francisco (San Francisco) and UCLA Medical Center (Los Angeles)."

Answered by AI

Are there any remaining opportunities for participants to join this research?

"The details posted on clinicaltrials.gov suggest that this trial is still recruiting participants; it was first published on the 1st of January 2018, with its most recent update being issued in October 2021."

Answered by AI

What is the objective of this experiment?

"This trial has been designed to measure the hierarchical clinical composite as its primary efficacy objective. A number of secondary outcomes have also been detailed, including changes in NYHA classification, regurgitant volume, and left ventricular end-diastolic volume over a 12 month time frame."

Answered by AI