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Exercise in Chronically Paced Children

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: NCT00374608
Recruitment Status : Completed
First Posted : September 11, 2006
Last Update Posted : June 1, 2012
Children's Healthcare of Atlanta
Information provided by (Responsible Party):
Patricio A. Frias, MD, Emory University

Brief Summary:
The purpose of this study is to evaluate the exercise capacity of patients with complete heart block who are chronically being paced from the right ventricle. Also, we hope to correlate the level of uncoordinated contraction with the patients exercise capacity. We will enroll patients with complete heart block as diagnosed by standard electrocardiographic means and now have a permanent pacemaker. All patients we approach for this study will receive an echocardiogram to assess their heart function. As part of the echocardiogram, they will also receive a Tissue Synchronization Imaging (TSI) evaluation to assess the level of uncoordinated contraction they have. The patients will then be subjected to a cardiac exercise stress test which will involve them running on a treadmill until they cannot continue while data is collected regarding their heart's response to exercise. All portions of the study are noninvasive, which means they work from probes and monitors outside the body.

Condition or disease
Congenital Diseases Complete Heart Block Pacemaker

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Study Type : Observational
Actual Enrollment : 25 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: A Single Center, Prospective, Pilot Study Examining the Evaluation of Exercise Capacity in Chronically RV Paced Children and Young Adults
Study Start Date : January 2007
Actual Primary Completion Date : July 2009
Actual Study Completion Date : July 2009

Information from the National Library of Medicine

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Ages Eligible for Study:   10 Years to 21 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
pt who have congenital complete heart block with no other preexisting condition that precludes the patient from exercise

Inclusion Criteria:

  • between 10 and 21 years of age
  • structurally normal heart
  • congenital complete heart block
  • dual chamber pacemaker, right ventricular apex paced
  • normal function via traditional transthoracic echocardiography

Exclusion Criteria:

  • preexisting condition that precludes patient from exercise
  • 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): NCT00374608

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United States, Georgia
Children's Healthcare of Atlanta - Egleston
Atlanta, Georgia, United States, 30322
Sponsors and Collaborators
Emory University
Children's Healthcare of Atlanta
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Principal Investigator: Patricio A Frias, MD Emory University and Children's Healthcare of Atlanta

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Responsible Party: Patricio A. Frias, MD, Associate Professor, Pediatrics, Emory University Identifier: NCT00374608    
Other Study ID Numbers: 291-2006
First Posted: September 11, 2006    Key Record Dates
Last Update Posted: June 1, 2012
Last Verified: May 2012
Keywords provided by Patricio A. Frias, MD, Emory University:
congenital complete heart block
dual chamber pacemaker
Additional relevant MeSH terms:
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Heart Block
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Cardiac Conduction System Disease
Pathologic Processes