CRT Pilot Study for Children With Heart Failure

This study has been completed.
Information provided by (Responsible Party):
University of Utah Identifier:
First received: December 21, 2007
Last updated: January 7, 2016
Last verified: January 2016
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 ] [ Designated as safety issue: No ]

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 ] [ Designated as safety issue: No ]

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


Ages Eligible for Study:   1 Year to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Primary care clinic

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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Please refer to this study by its identifier: NCT00585065

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

Responsible Party: University of Utah Identifier: NCT00585065     History of Changes
Other Study ID Numbers: 00015291  IRB#: 00015291 
Study First Received: December 21, 2007
Last Updated: January 7, 2016
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Heart Failure
Cardiovascular Diseases
Heart Diseases processed this record on May 01, 2016