Carillon Mitral Contour System for Heart Failure

The EMPOWER Trial - The Carillon Mitral Contour System® in Treating Heart Failure With FMR

Recruiting N/A Interventional Study
Functional Mitral Regurgitation Heart Failure Mitral Valve Insufficiency Heart Diseases Cardiovascular Diseases Heart Valve Diseases
No Placebo Group Every participant receives an active treatment — no one gets a placebo.
Ready to participate?

Review the details below, then apply to join this clinical trial.

At a Glance
Age
18 and older
Sex
Any
Study type
Interventional
Purpose
Treatment
Participants needed
300 (estimated)
Sponsor
Cardiac Dimensions, Inc. · Industry
Who this trial is looking for

This trial is looking for individuals with heart failure and a specific type of mitral valve problem. Participants will be randomly assigned to receive either the treatment or a control and will need to attend follow-up visits.

Are You a Good Fit for This Trial?

You may be able to join if

  • I have heart failure with mild to moderate mitral regurgitation.
  • I have a six-minute walk distance of at least 100 meters.
  • I am at least 18 years old.
  • I have a left ventricular ejection fraction of 50% or less.
  • I have had heart failure issues within the past year.
  • I am currently taking heart failure medications as prescribed.
  • The doctor can place the Carillon implant in me.

You may not be able to join if

  • I have a mechanical or bio-prosthetic mitral valve.
  • I have severe issues with my mitral valve.
  • I have severe tricuspid regurgitation.
  • I have severe aortic stenosis.
  • I am expected to need cardiac surgery in the next year.
  • I have other serious medical conditions that could shorten my life.

Summarized in plain language from this trial's official eligibility criteria. The full criteria are further down this page — only the research team can confirm whether you qualify.

Think this trial could be right for you?

Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.

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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).

Trial Locations
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Eligibility Criteria
Inclusion Criteria: 1. Symptomatic heart failure with functional (secondary) mitral regurgitation of at least 1+ (mild) severity 2. NYHA II, III, or IV 3. Six Minute Walk distance ≥ 100 meters and ≤ 600 meters 4. Left Ventricular Ejection Fraction ≤ 50% 5. LVEDD: * ≥ 55 mm (women) * ≥ 57 mm …
Contacts

Hank Hauser

(310) 228-0016

hhauser@cardiacdimensions.com

CONTACT