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Ensure Cardiac Resynchronization Therapy Study

This study has been completed.
Sponsor:
Collaborator:
Medtronic
Information provided by:
Medtronic Cardiac Rhythm Disease Management
ClinicalTrials.gov Identifier:
NCT00291564
First received: February 10, 2006
Last updated: December 17, 2007
Last verified: December 2007
History of Changes
  Purpose

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:

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

Further study details as provided by Medtronic Cardiac Rhythm Disease Management:

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00291564

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

No publications provided

ClinicalTrials.gov Identifier: NCT00291564     History of Changes
Other Study ID Numbers: 239
Study First Received: February 10, 2006
Last Updated: December 17, 2007
Health Authority: United States: Institutional Review Board

Keywords provided by Medtronic Cardiac Rhythm Disease Management:
Observational
Heart Failure
Continuous Cardiac Resynchronization Therapy

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on May 19, 2013