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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 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.

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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).

Conditions Studied

Heart Failure Cardiovascular Diseases Heart Diseases Heart Valve Diseases Mitral Valve Insufficiency Functional Mitral Regurgitation

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

Sponsor

Cardiac Dimensions

1 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT03142152

The ClinicalTrials.gov registry entry for NCT03142152 describes a study currently listed as recruiting, categorized as NA. The registered enrollment target is 300 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 2,048-participant average among 397 other Heart Failure trials with a reported enrollment target (85% lower). The listed sponsor is Cardiac Dimensions, which has 1 total studies on file at ClinicalTrials.gov.

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 reports 20 study locations spanning 6 distinct geographic areas - top geographies include 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.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.