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CRT Pilot Study for Children With Heart Failure

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00585065
First Posted: January 3, 2008
Last Update Posted: January 11, 2016
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.
Information provided by (Responsible Party):
University of Utah
  Purpose
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 Intervention
Chronic Pediatric Heart Failure Other: Cardiac Resynchronization Therapy

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Cardiac Resynchronization Therapy for Children and Adolescents With Advanced Hearth Failure: A Pilot Study

Resource links provided by NLM:


Further study details as provided by University of Utah:

Primary Outcome Measures:
  • 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:
  • 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 ]

Enrollment: 7
Study Start Date: January 2006
Study Completion Date: January 2008
Primary Completion Date: January 2008 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
1 Other: Cardiac Resynchronization Therapy
Cardiac Resynchronization Therapy

  Eligibility

Information from the National Library of Medicine

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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
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
United States, Utah
University of Utah
Salt Lake City, Utah, United States, 84112
Sponsors and Collaborators
University of Utah
Investigators
Principal Investigator: Elizabeth Saarel, MD University of Utah
  More Information

Responsible Party: University of Utah
ClinicalTrials.gov Identifier: NCT00585065     History of Changes
Other Study ID Numbers: 00015291
IRB#: 00015291
First Submitted: December 21, 2007
First Posted: January 3, 2008
Last Update Posted: January 11, 2016
Last Verified: January 2016

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases