NCT00205192

Brief Summary

Cardiac resynchronization therapy shows great promise as a method to improve ventricular function in heart failure due to dilated cardiomyopathy. It is applied to patients with class III and IV symptomatic heart failure on optimal therapy. Typical entry criteria in the trials testing resynchronization have used the electrocardiogram and a prolonged electrocardiogram (ECG) QRS interval as criteria for dyssynchrony. This is recognized to be quite limited as a tool for identifying patients. Several new echocardiographic methods for identifying dyssynchrony have been proposed. The purpose of this study is to systematically examine these multiple echocardiographic measurement techniques in three conditions:

  1. 1.in the patient's native rhythm simulated by changing the pacing system to atrial pacing only;
  2. 2.in conventional dual chamber pacing (DDD mode); and
  3. 3.during biventricular pacing. All patients entered into this study will already have had a biventricular pacemaker placed.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jun 2004

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

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

June 1, 2004

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

September 12, 2005

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 20, 2005

Completed
6.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2011

Completed
Last Updated

August 29, 2012

Status Verified

August 1, 2012

Enrollment Period

7.5 years

First QC Date

September 12, 2005

Last Update Submit

August 28, 2012

Conditions

Keywords

Heart FailureCardiac resynchronizationechocardiography

Interventions

various pacemaker modes used over 1 hour

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients who have previously had a resynchronization pacemaker system placed at the University of Wisconsin Hospital or at the Middleton Veterans Hospital are potentially eligible for this study.

You may qualify if:

  • All patients who have previously had a resynchronization pacemaker system placed at the University of Wisconsin Hospital or at the Middleton Veterans Hospital are potentially eligible for this study.
  • The study is only open to patients as enumerated above, and also patients who have good imaging windows.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Wisconsin

Madison, Wisconsin, 53792, United States

Location

MeSH Terms

Conditions

Heart Failure

Interventions

Cardiac Resynchronization Therapy

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Cardiac Pacing, ArtificialElectric Stimulation TherapyTherapeutics

Study Officials

  • Peter S Rahko, MD

    University of Wisconsin, Madison

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 12, 2005

First Posted

September 20, 2005

Study Start

June 1, 2004

Primary Completion

December 1, 2011

Study Completion

December 1, 2011

Last Updated

August 29, 2012

Record last verified: 2012-08

Locations