Resynchronization Therapy in Young Patients With and Without CHD
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Purpose
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 |
|---|
|
Dilated Cardiomyopathy Pediatric |
| Study Type: | Observational |
| Study Design: | Observational Model: Defined Population Observational Model: Natural History Time Perspective: Longitudinal 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 |
| Estimated Enrollment: | 50 |
| Study Start Date: | June 2004 |
| Estimated Study Completion Date: | December 2006 |
Show Detailed Description
Eligibility| Ages Eligible for Study: | up to 18 Years |
| Genders Eligible for Study: | Both |
| 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
Contacts and Locations| United States, Georgia | |
| Children's Healthcare of Atlanta | |
| Atlanta, Georgia, United States, 30322 | |
| Principal Investigator: | Margaret Strieper, DO | Emory University and Children's Healthcare of Atlanta |
More Information
Publications:
| ClinicalTrials.gov Identifier: | NCT00208806 History of Changes |
| Other Study ID Numbers: | 418-2004 |
| Study First Received: | September 13, 2005 |
| Last Updated: | February 5, 2007 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Emory University:
|
Dilated Cardiomyopathy Pediatric Bi-ventricular Pacemaker |
Additional relevant MeSH terms:
|
Cardiomyopathy, Dilated Ventricular Dysfunction Cardiomyopathies |
Cardiomegaly Heart Diseases Cardiovascular Diseases |
ClinicalTrials.gov processed this record on May 16, 2013