CRT Pilot Study for Children With Heart Failure

This study is ongoing, but not recruiting participants.

First Received: December 21, 2007 Last Updated: July 11, 2008 History of Changes

Sponsored by:	University of Utah
Information provided by:	University of Utah
ClinicalTrials.gov Identifier:	NCT00585065

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

MedlinePlus related topics: Heart Failure

U.S. FDA Resources

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

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 ]

Biospecimen Retention: None Retained

Biospecimen Description:

Estimated Enrollment:	7
Study Start Date:	January 2006
Estimated Study Completion Date:	January 2009
Estimated Primary Completion Date:	January 2009 (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:	Univerisity of Utah ( University of Utah )
Study ID Numbers:	00015291, IRB#: 00015291
Study First Received:	December 21, 2007
Last Updated:	July 11, 2008
ClinicalTrials.gov Identifier:	NCT00585065 History of Changes
Health Authority:	United States: Institutional Review Board

Study placed in the following topic categories:

Heart Failure
Heart Diseases

Additional relevant MeSH terms:

Heart Failure
Heart Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on May 07, 2009