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Resynchronization Therapy in Young Patients With and Without CHD

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00208806
Recruitment Status : Completed
First Posted : September 21, 2005
Last Update Posted : December 10, 2013
Information provided by (Responsible Party):
Margaret Strieper, Emory University

Brief Summary:

Pacemakers can be attached to one or more than one of the heart chambers. After watching pacemakers work over time, doctors have found that the pacemakers that stimulate only one chamber of the heart sometimes lead to problems later. These problems may be changes in the size and shape of the heart. The heart cannot work as well when some of these changes happen. We need to learn more about these changes and how to prevent them. There has not been an easy way to do this. A new treatment called Cardiac Resynchronization Therapy (CRT) is associated with biventricular pacing where two chambers of the heart are stimulated simultaneously. Tissue Doppler Imaging,Tissue Synchronization Imaging and 3 dimensional echocardiography are new forms of technology that look at the heart while it works. They are similar to a moving x-ray that can watch the heart muscles moving. The movement can be measured. Doctors will check for changes that happen over time. This has not been studied in children before because this kind of is new to this group of patients. This technology is noninvasive which means it can be done from the outside of the body and is painless.

The hearts of children grow fast. It is important to be able to know if the pacemaker or problems from dilated cardiomyopathy are causing any changes in the heart that might cause problems. We expect to be able to use information we learn from this study to improve how we use pacemakers in the future to avoid problems that can happen over time.

Condition or disease Intervention/treatment
Dilated Cardiomyopathy Pediatric Other: congestive heart failure patients

  Show Detailed Description

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Study Type : Observational
Enrollment : 50 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Clinical Evaluation of Dilated Cardiomyopathy and Cardiac Resynchronization Therapy for Ventricular Dysfunction in Young Patients With and Without Congenital Heart Disease
Study Start Date : June 2004
Actual Primary Completion Date : December 2006
Actual Study Completion Date : December 2006

Group/Cohort Intervention/treatment
congenital heart patients with congestive heart failure
20 effected patients with congestive heart failure patients total 50 patients
Other: congestive heart failure patients
observational echo data on congestive heart failure patients

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Diagnosed with dilated cardiomyopathy
  • normal heart anatomy or those with repaired congenital defects that have a 4 chambered heart
  • referred for a Biventricular pacemaker implantation or upgrade with the diagnosis of dilated cardiomyopathy or for an echocardiogram due to the diagnosis of dilated cardiomyopathy without pacemaker
  • signed informed consent

Exclusion Criteria:

  • cannot travel back to Children's Healthcare of Atlanta for follow-up
  • Patients with a transplanted heart
  • no informed consent

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00208806

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United States, Georgia
Children's Healthcare of Atlanta
Atlanta, Georgia, United States, 30322
Sponsors and Collaborators
Emory University
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Principal Investigator: Margaret Strieper, DO Emory University and Children's Healthcare of Atlanta

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Responsible Party: Margaret Strieper, Principal Investigator, Emory University Identifier: NCT00208806     History of Changes
Other Study ID Numbers: 0418-2004
First Posted: September 21, 2005    Key Record Dates
Last Update Posted: December 10, 2013
Last Verified: December 2013
Keywords provided by Margaret Strieper, Emory University:
Dilated Cardiomyopathy
Bi-ventricular Pacemaker
Additional relevant MeSH terms:
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Cardiomyopathy, Dilated
Heart Diseases
Cardiovascular Diseases