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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 July 29, 2014