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CRT Pilot Study for Children With Heart Failure

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University of Utah
ClinicalTrials.gov Identifier:
NCT00585065
First received: December 21, 2007
Last updated: January 7, 2016
Last verified: January 2016

December 21, 2007
January 7, 2016
January 2006
January 2008   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT00585065 on ClinicalTrials.gov Archive Site
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 ]
Same as current
Not Provided
Not Provided
 
CRT Pilot Study for Children With Heart Failure
Cardiac Resynchronization Therapy for Children and Adolescents With Advanced Hearth Failure: A Pilot Study
To collect information on pediatric patients receiving Cardiac Resynchronization Therapy (CRT) with permanent biventricular pacing (BVP) as a method of treating chronic heart failure.
Not Provided
Observational
Time Perspective: Prospective
Not Provided
Not Provided
Probability Sample
Primary care clinic
Chronic Pediatric Heart Failure
Other: Cardiac Resynchronization Therapy
Cardiac Resynchronization Therapy
1
Intervention: Other: Cardiac Resynchronization Therapy
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
7
January 2008
January 2008   (final data collection date for primary outcome measure)

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.
Both
1 Year to 18 Years   (Child, Adult)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00585065
00015291, IRB#: 00015291
No
Not Provided
Not Provided
University of Utah
University of Utah
Not Provided
Principal Investigator: Elizabeth Saarel, MD University of Utah
University of Utah
January 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP