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NCT03142152 · ClinicalTrials.gov registry record · NA

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

A NA study of Heart Failure and Cardiovascular Diseases, sponsored by Cardiac Dimensions.

Recruiting
Registry status
NA
Development phase
300
Enrollment target
20
Study locations

NCT03142152: Recruiting NA study of Heart Failure and Cardiovascular Diseases, sponsored by Cardiac Dimensions.

NCT03142152 is a NA study of Heart Failure and Cardiovascular Diseases that is actively recruiting participants, run by Cardiac Dimensions. The registered enrollment target is 300 participants, below the 2,048-participant average among 397 other Heart Failure trials with a reported enrollment target (85% lower). The trial reports 20 study locations across 6 states. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT03142152, a NA study of Heart Failure and Cardiovascular Diseases, is actively recruiting participants, sponsored by Cardiac Dimensions.

RECRUITING
Registry status
NA
Development phase
300 participants
Enrollment target
20
Study locations

Study Summary

The objective of this prospective, randomized, blinded clinical trial is to assess the safety and efficacy of the Carillon Mitral Contour System in treating heart failure with functional regurgitation (FMR).

Primary Outcome

Freedom from a composite of major adverse events (defined as Device Embolization, Vessel Erosion, Cardiac Perforation, and occurrence of cardiac surgery or percutaneous coronary intervention) in the Intervention group is greater than performance goal of 90%.

Interventions

  • DEVICE Carillon Mitral Contour System
  • OTHER Guideline Directed Heart Failure Medication

Study Locations (20)

California

  • Memorial Care Hospital - Long Beach
  • Keck School of Medicine of USC - Los Angeles
  • UCLA Medical Center - Los Angeles
  • Stanford University - Redwood City
  • Scripps Health - San Diego
  • University of California- San Francisco - San Francisco

Florida

  • Delray Medical Center - Delray Beach
  • University of Miami - Miami
  • Advent Health Hospital - Orlando
  • Palm Beach Gardens Medical - Palm Beach
  • Tallahassee Research Institute - Tallahassee
  • Tampa General Hospital - Tampa

Arizona

  • Dignity Health Research Institute at Mercy Gilbert and Chandler Regional Medical Centers - Gilbert
  • Banner Health - Phoenix - Phoenix
  • Tucson Medical Center Health - Tucson
  • Banner University Tuscon - Tucson

Georgia

  • Augusta University Research Institute - Augusta
  • Wellstar Health System, - Marietta

Colorado

  • South Denver Cardiology - Littleton

District of Columbia

  • Medstar - Washington D.C.

Trial Details

FieldValue
Enrollment Target 300 participants
Start Date 2018-01-01
Est. Completion 2030-12-31
Phase NA
Cardiac Dimensions

1 total trials

What NCT03142152 shows while recruiting

NCT03142152 is an interventional study that assigns participants to a tested intervention. The registered 300 participants enrollment target is mid-sized for trials with a published cap, below the 2,048-participant average among 397 other Heart Failure trials with a reported enrollment target (85% lower).

The record links to 6 conditions, with Heart Failure appearing as the primary indexed condition, and to 2 interventions - of which Carillon Mitral Contour System is the first listed.

NCT03142152 names 20 study sites across 6 states, led by California, Florida, Arizona.

Frequently Asked Questions

What is clinical trial NCT03142152 about?

NCT03142152 is a clinical study titled "The EMPOWER Trial - The Carillon Mitral Contour System® in Treating Heart Failure With at Least Mild FMR". The objective of this prospective, randomized, blinded clinical trial is to assess the safety and efficacy of the Carillon Mitral Contour System in treating heart failure with functional regurgitation (FMR).

What is the current status of trial NCT03142152?

This trial is currently recruiting. It is a NA study. The enrollment target is 300 participants. The study started on 2018-01-01. Estimated completion is 2030-12-31.

What conditions does trial NCT03142152 study?

This clinical trial studies the following conditions: Heart Failure, Cardiovascular Diseases, Heart Diseases, Heart Valve Diseases, Mitral Valve Insufficiency.

What interventions are being tested in trial NCT03142152?

The interventions under investigation include: Carillon Mitral Contour System (DEVICE), Guideline Directed Heart Failure Medication (OTHER).

Who is sponsoring clinical trial NCT03142152?

This trial is sponsored by Cardiac Dimensions, which has 1 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT03142152 being conducted?

This trial has 20 study locations across Arizona, California, Colorado, District of Columbia, Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Similar trials for Heart Failure

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT03142152's enrollment target sits among peer trials

300 138th of 397 higher than 253 of 397 other Heart Failure trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Heart Failure trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT03142152, the US trial registry maintained by the National Library of Medicine. NCT03142152 (mid enrollment · wide site footprint · recruiting) retrieved and formatted by PlainTrial, see methodology.