Ensure Cardiac Resynchronization Therapy Study - Tabular View

This Tabular View shows the required WHO registration data elements as marked by ^†

Tracking Information

First Received Date ^†

February 10, 2006

Last Updated Date

December 17, 2007

Start Date ^†

May 2004

Current Primary Outcome Measures ^†

Original Primary Outcome Measures ^†

Change History

Complete list of historical versions of study NCT00291564 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^†

Original Secondary Outcome Measures ^†

Descriptive Information

Brief Title ^†

Ensure Cardiac Resynchronization Therapy Study

Official Title ^†

Ensure Cardiac Resynchronization Therapy Study

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.

Detailed Description

Study Phase

Study Type ^†

Observational

Study Design ^†

Prospective

Condition ^†

Heart Failure

Intervention ^†

Device: Cardiac Resynchronization Therapy Device

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^†

Completed

Enrollment ^†

430

Completion Date

February 2006

Primary Completion Date

Eligibility 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

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^††

Location Countries ^†

United States

Expanded Access Status

Administrative Information

NCT ID ^†

NCT00291564

Responsible Party

Secondary IDs ^††

Study Sponsor ^†

Medtronic Cardiac Rhythm Disease Management

Collaborators ^††

Medtronic

Investigators ^†

Principal Investigator:

David Thompson, MD

Tennessee Cardiovascular Research Institute

Information Provided By

Medtronic Cardiac Rhythm Disease Management

Verification Date

December 2007

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.