Ensure Cardiac Resynchronization Therapy Study

This study has been completed.

Sponsors and Collaborators:	Medtronic Cardiac Rhythm Disease Management Medtronic
Information provided by:	Medtronic Cardiac Rhythm Disease Management
ClinicalTrials.gov Identifier:	NCT00291564

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

MedlinePlus related topics: Heart Failure

U.S. FDA Resources

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

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

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

Keywords provided by Medtronic Cardiac Rhythm Disease Management:

Observational
Heart Failure
Continuous Cardiac Resynchronization Therapy

Study placed in the following topic categories:

Heart Failure
Heart Diseases

Additional relevant MeSH terms:

Cardiovascular Diseases

ClinicalTrials.gov processed this record on January 16, 2009