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CRT Pilot Study for Children With Heart Failure

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.
 
ClinicalTrials.gov Identifier: NCT00585065
Recruitment Status : Completed
First Posted : January 3, 2008
Last Update Posted : January 11, 2016
Sponsor:
Information provided by (Responsible Party):
University of Utah

Study Description
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Brief Summary:
To collect information on pediatric patients receiving Cardiac Resynchronization Therapy (CRT) with permanent biventricular pacing (BVP) as a method of treating chronic heart failure.

Condition or disease Intervention/treatment
Chronic Pediatric Heart Failure Other: Cardiac Resynchronization Therapy

Study Design
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Study Type : Observational
Actual Enrollment : 7 participants
Time Perspective: Prospective
Official Title: Cardiac Resynchronization Therapy for Children and Adolescents With Advanced Hearth Failure: A Pilot Study
Study Start Date : January 2006
Actual Primary Completion Date : January 2008
Actual Study Completion Date : January 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Failure

Groups and Cohorts
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Group/Cohort Intervention/treatment
1 Other: Cardiac Resynchronization Therapy
Cardiac Resynchronization Therapy


Outcome Measures
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Primary Outcome Measures :
  1. Describe and evaluate clinical and hemodynamic effects of CRT using BVP in children and adolescents with advanced heart failure [ Time Frame: Jan 2006-Jan 2009 ]

Secondary Outcome Measures :
  1. Describe the relationships between ECG measures of mechanical dyssynchrony and subject response to CRT in children and adolescents with advanced heart failure [ Time Frame: Jan 2006-Jan 2009 ]

Eligibility Criteria
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Ages Eligible for Study:   1 Year to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Primary care clinic
Criteria

Inclusion Criteria:

  • Chronic and severe heart failure, NYHA class III or IV
  • Pts optimized and stable on diuretics and afterload reducing agents (with or without inotropes) for at least 1 week prior to enrollment
  • Chronic systemic ventricular dysfunction as defined in the protocol.
Contacts and Locations
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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 ClinicalTrials.gov identifier (NCT number): NCT00585065


Locations
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United States, Utah
University of Utah
Salt Lake City, Utah, United States, 84112
Sponsors and Collaborators
University of Utah
Investigators
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Principal Investigator: Elizabeth Saarel, MD University of Utah
More Information
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Responsible Party: University of Utah
ClinicalTrials.gov Identifier: NCT00585065    
Other Study ID Numbers: 00015291
IRB#: 00015291
First Posted: January 3, 2008    Key Record Dates
Last Update Posted: January 11, 2016
Last Verified: January 2016
Additional relevant MeSH terms:
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Heart Failure
Heart Diseases
Cardiovascular Diseases