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CRT Pilot Study for Children With Heart Failure

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
elizabeth saarel, University of Utah
ClinicalTrials.gov Identifier:
NCT00585065
First received: December 21, 2007
Last updated: March 20, 2013
Last verified: March 2013
History of Changes
  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:

MedlinePlus related topics: Heart Failure
U.S. FDA Resources

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 ]

Estimated Enrollment: 7
Study Start Date: January 2006
Estimated Study Completion Date: January 2015
Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
1 Other: Cardiac Resynchronization Therapy
Cardiac Resynchronization Therapy

  Eligibility

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

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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: elizabeth saarel, Associate Professor, University of Utah
ClinicalTrials.gov Identifier: NCT00585065     History of Changes
Other Study ID Numbers: 00015291, IRB#: 00015291
Study First Received: December 21, 2007
Last Updated: March 20, 2013
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on May 19, 2013