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

NCT03142152 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 300

Last updated 2026-04-13

No results posted yet for this study

Summary

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).

Conditions

Interventions

DEVICE

Carillon Mitral Contour System

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.

OTHER

Guideline Directed Heart Failure Medication

Heart failure medication per ACC/AHA guidelines

Sponsors & Collaborators

  • Cardiac Dimensions, Inc.

    lead INDUSTRY

Principal Investigators

  • Samir Kapadia, MD · The Cleveland Clinic

  • Randall Starling, MD · The Cleveland Clinic

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-01-01
Primary Completion
2026-12-31
Completion
2030-12-31
FDA Device
Yes

Countries

  • United States
  • Canada
  • France
  • Greece
  • Italy
  • Poland
  • Spain
  • United Kingdom

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03142152 on ClinicalTrials.gov