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Ensure Cardiac Resynchronization Therapy Study

This study has been completed.
Information provided by:
Medtronic Cardiac Rhythm and Heart Failure Identifier:
First received: February 10, 2006
Last updated: December 17, 2007
Last verified: December 2007
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 Intervention
Heart Failure
Device: Cardiac Resynchronization Therapy Device

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Ensure Cardiac Resynchronization Therapy Study

Resource links provided by NLM:

Further study details as provided by Medtronic Cardiac Rhythm and Heart Failure:

Estimated Enrollment: 430
Study Start Date: May 2004
Study Completion Date: February 2006

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
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, see Learn About Clinical Studies.

Please refer to this study by its identifier: 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 Identifier: NCT00291564     History of Changes
Other Study ID Numbers: 239
Study First Received: February 10, 2006
Last Updated: December 17, 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 processed this record on May 24, 2017