We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov Menu

Ensure Cardiac Resynchronization Therapy Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00291564
Recruitment Status : Completed
First Posted : February 14, 2006
Last Update Posted : December 21, 2007
Information provided by:

Study Description
Brief Summary:
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.

Condition or disease Intervention/treatment
Heart Failure Device: Cardiac Resynchronization Therapy Device

Study Design

Study Type : Observational
Estimated Enrollment : 430 participants
Time Perspective: Prospective
Official Title: Ensure Cardiac Resynchronization Therapy Study
Study Start Date : May 2004
Study Completion Date : February 2006

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Failure
U.S. FDA Resources

Groups and Cohorts

Outcome Measures

Eligibility Criteria

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00291564

  Show 32 Study Locations
Sponsors and Collaborators
Medtronic Cardiac Rhythm and Heart Failure
Principal Investigator: David Thompson, MD Tennessee Cardiovascular Research Institute
More Information

ClinicalTrials.gov Identifier: NCT00291564     History of Changes
Other Study ID Numbers: 239
First Posted: February 14, 2006    Key Record Dates
Last Update Posted: December 21, 2007
Last Verified: December 2007

Keywords provided by Medtronic Cardiac Rhythm and Heart Failure:
Heart Failure
Continuous Cardiac Resynchronization Therapy

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases