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

Tracking Information

First Received Date ^ICMJE

December 21, 2007

Last Updated Date

March 20, 2013

Start Date ^ICMJE

January 2006

Primary Completion Date

January 2013 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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 ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00585065 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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 ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

CRT Pilot Study for Children With Heart Failure

Official Title ^ICMJE

Cardiac Resynchronization Therapy for Children and Adolescents With Advanced Hearth Failure: A Pilot Study

Brief Summary

To collect information on pediatric patients receiving Cardiac Resynchronization Therapy (CRT) with permanent biventricular pacing (BVP) as a method of treating chronic heart failure.

Detailed Description

Not Provided

Study Type ^ICMJE

Observational

Study Design ^ICMJE

Time Perspective: Prospective

Target Follow-Up Duration

Not Provided

Biospecimen

Not Provided

Sampling Method

Probability Sample

Study Population

Primary care clinic

Condition ^ICMJE

Chronic Pediatric Heart Failure

Intervention ^ICMJE

Other: Cardiac Resynchronization Therapy

Cardiac Resynchronization Therapy

Study Group/Cohort (s)

Intervention: Other: Cardiac Resynchronization Therapy

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Active, not recruiting

Estimated Enrollment ^ICMJE

Estimated Completion Date

January 2015

Primary Completion Date

January 2013 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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.

Gender

Both

Ages

1 Year to 18 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT00585065

Other Study ID Numbers ^ICMJE

00015291, IRB#: 00015291

Has Data Monitoring Committee

Responsible Party

elizabeth saarel, University of Utah

Study Sponsor ^ICMJE

University of Utah

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

Elizabeth Saarel, MD

University of Utah

Information Provided By

University of Utah

Verification Date

March 2013

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

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