NCT00291564

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
430

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 2004

Geographic Reach
1 country

32 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2004

Completed
1.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2006

Completed
9 days until next milestone

First Submitted

Initial submission to the registry

February 10, 2006

Completed
4 days until next milestone

First Posted

Study publicly available on registry

February 14, 2006

Completed
Last Updated

December 21, 2007

Status Verified

December 1, 2007

First QC Date

February 10, 2006

Last Update Submit

December 17, 2007

Conditions

Keywords

ObservationalHeart FailureContinuous Cardiac Resynchronization Therapy

Interventions

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (32)

Unknown Facility

Birmingham, Alabama, United States

Location

Unknown Facility

Newport Beach, California, United States

Location

Unknown Facility

Trumbull, Connecticut, United States

Location

Unknown Facility

Daytona Beach, Florida, United States

Location

Unknown Facility

Augusta, Georgia, United States

Location

Unknown Facility

Kankakee, Illinois, United States

Location

Unknown Facility

Indianapolis, Indiana, United States

Location

Unknown Facility

Des Moines, Iowa, United States

Location

Unknown Facility

Owensboro, Kentucky, United States

Location

Unknown Facility

New Orleans, Louisiana, United States

Location

Unknown Facility

Salisbury, Maryland, United States

Location

Unknown Facility

Burlington, Massachusetts, United States

Location

Unknown Facility

Detroit, Michigan, United States

Location

Unknown Facility

Traverse City, Michigan, United States

Location

Unknown Facility

Minneapolis, Minnesota, United States

Location

Unknown Facility

Mexico, Missouri, United States

Location

Unknown Facility

Omaha, Nebraska, United States

Location

Unknown Facility

Bridgewater, New Jersey, United States

Location

Unknown Facility

Englewood, New Jersey, United States

Location

Unknown Facility

Charlotte, North Carolina, United States

Location

Unknown Facility

Dayton, Ohio, United States

Location

Unknown Facility

Lyndhurst, Ohio, United States

Location

Unknown Facility

Oklahoma City, Oklahoma, United States

Location

Unknown Facility

Portland, Oregon, United States

Location

Unknown Facility

Abington, Pennsylvania, United States

Location

Unknown Facility

Doylestown, Pennsylvania, United States

Location

Unknown Facility

Columbia, South Carolina, United States

Location

Unknown Facility

Nashville, Tennessee, United States

Location

Unknown Facility

Houston, Texas, United States

Location

Unknown Facility

Fairfax, Virginia, United States

Location

Unknown Facility

Richmond, Virginia, United States

Location

Unknown Facility

Seattle, Washington, United States

Location

MeSH Terms

Conditions

Heart Failure

Interventions

Cardiac Resynchronization Therapy Devices

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Pacemaker, ArtificialElectrodesElectrical Equipment and SuppliesEquipment and Supplies

Study Officials

  • David Thompson, MD

    Tennessee Cardiovascular Research Institute

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

February 10, 2006

First Posted

February 14, 2006

Study Start

May 1, 2004

Study Completion

February 1, 2006

Last Updated

December 21, 2007

Record last verified: 2007-12

Locations