Ensure Cardiac Resynchronization Therapy Study

December 17, 2007 updated by: Medtronic Cardiac Rhythm and Heart Failure
The purpose of this study is to gather information on how doctors program particular settings on cardiac resynchronization therapy implantable cardiac defibrillators (CRT-Ds), to analyze how these settings affect the amount of cardiac resynchronization therapy (CRT) patients receive and to evaluate the therapy approach for converting abnormally fast heartbeats into normal heartbeats. There are no experimental devices or procedures involved in this study.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment

430

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Alabama
      • Birmingham, Alabama, United States
    • California
      • Newport Beach, California, United States
    • Connecticut
      • Trumbull, Connecticut, United States
    • Florida
      • Daytona Beach, Florida, United States
    • Georgia
      • Augusta, Georgia, United States
    • Illinois
      • Kankakee, Illinois, United States
    • Indiana
      • Indianapolis, Indiana, United States
    • Iowa
      • Des Moines, Iowa, United States
    • Kentucky
      • Owensboro, Kentucky, United States
    • Louisiana
      • New Orleans, Louisiana, United States
    • Maryland
      • Salisbury, Maryland, United States
    • Massachusetts
      • Burlington, Massachusetts, United States
    • Michigan
      • Detroit, Michigan, United States
      • Traverse City, Michigan, United States
    • Minnesota
      • Minneapolis, Minnesota, United States
    • Missouri
      • Mexico, Missouri, United States
    • Nebraska
      • Omaha, Nebraska, United States
    • New Jersey
      • Bridgewater, New Jersey, United States
      • Englewood, New Jersey, United States
    • North Carolina
      • Charlotte, North Carolina, United States
    • Ohio
      • Dayton, Ohio, United States
      • Lyndhurst, Ohio, United States
    • Oklahoma
      • Oklahoma City, Oklahoma, United States
    • Oregon
      • Portland, Oregon, United States
    • Pennsylvania
      • Abington, Pennsylvania, United States
      • Doylestown, Pennsylvania, United States
    • South Carolina
      • Columbia, South Carolina, United States
    • Tennessee
      • Nashville, Tennessee, United States
    • Texas
      • Houston, Texas, United States
    • Virginia
      • Fairfax, Virginia, United States
      • Richmond, Virginia, United States
    • Washington
      • Seattle, Washington, United States

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patient is indicated for a Medtronic CRT-D system
  • Patient is willing to sign Permission for Access to and Use of Health Information form
  • Patient is willing and able to comply with follow-up visits through six months

Exclusion Criteria:

  • Patient has a life expectancy of less than 6 months
  • Patient is participating in any concurrent study that could confound the results for either study

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medtronic Cardiac Rhythm and Heart Failure

Collaborators

Medtronic

Investigators

  • Principal Investigator: David Thompson, MD, Tennessee Cardiovascular Research Institute

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2004

Study Completion (Actual)

February 1, 2006

Study Registration Dates

First Submitted

February 10, 2006

First Submitted That Met QC Criteria

February 10, 2006

First Posted (Estimate)

February 14, 2006

Study Record Updates

Last Update Posted (Estimate)

December 21, 2007

Last Update Submitted That Met QC Criteria

December 17, 2007

Last Verified

December 1, 2007

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 239

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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