Optimizing Cardiac Resynchronization

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University of Wisconsin, Madison
ClinicalTrials.gov Identifier:
NCT00205192
First received: September 12, 2005
Last updated: August 28, 2012
Last verified: August 2012
  Purpose

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

Condition Intervention
Heart Failure
Procedure: Cardiac resynchronization pacing

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Optimizing Cardiac Resynchronization

Resource links provided by NLM:


Further study details as provided by University of Wisconsin, Madison:

Enrollment: 100
Study Start Date: June 2004
Study Completion Date: December 2011
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Intervention Details:
    Procedure: Cardiac resynchronization pacing
    various pacemaker modes used over 1 hour
  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-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.

Criteria

Inclusion Criteria:

  • 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00205192

Locations
United States, Wisconsin
University of Wisconsin
Madison, Wisconsin, United States, 53792
Sponsors and Collaborators
University of Wisconsin, Madison
Investigators
Principal Investigator: Peter S Rahko, MD University of Wisconsin, Madison
  More Information

No publications provided

Responsible Party: University of Wisconsin, Madison
ClinicalTrials.gov Identifier: NCT00205192     History of Changes
Other Study ID Numbers: H-2004-0335
Study First Received: September 12, 2005
Last Updated: August 28, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by University of Wisconsin, Madison:
Heart Failure
Cardiac resynchronization
echocardiography

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on October 01, 2014