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Completed

NCT Number: NCT00585065

CRT Pilot Study for Children With Heart Failure

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

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Key information

Conditions

Chronic Pediatric Heart Failure

Age range

1 year–18 year

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Utah

Salt Lake City, Utah, 84112, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Chronic and severe heart failure, NYHA class III or IV
  • Patients 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.
  • Intra ventricular conduction delay defined by spontaneous QRS duration > ULN for age.
  • All children from 1 to 18 years of age, both male and female, and all ethnic backgrounds.
  • Signed and dated informed consent.
  • Able to receive pectoral or abdominal implant.

Exclusion criteria

  • Suspected acute myocarditis.
  • Significant ventricular dysfunction, secondary to acquired or congenital heart defects amenable to surgical correction.
  • Acute coronary syndrome.
  • Adolescents who are pregnant.
  • Patient with BVP device implanted previously.
  • Patient has had prior/past heart transplantation.

Treatment and study plan

CRT device implant

Device

The purpose of this study is to collect information on patients with chronic heart failure who have already been identified by their physician as candidates for CRT. All tests, including device implantation are standard of care for patients undergoing CRT. The only test involved in this study that is not standard of care is the quality of life questionnaire. Patients who undergo CRT system implant will be followed post-implant (up to 1 week), and at one month, three months, six months and twelve months. The only test involved in this study that is not standard of care is the quality of life questionnaire.

Primary outcomes

  1. Collection of quality of life information using the Pediatric Quality of Life Inventory 4.0 (PedsQl v4.0) in children and adolescents with chronic, advanced heart failure (defined by NYHA Functional Classification).

    Time frame: Within 30 days of CRT implant to 12 months post implant

    Composed of 23 items comprising 4 dimensions. 5-point Likert scale from: 0 (Never) to 4 (Almost always).

    Higher scores = Better health related quality of life (HRQOL)

  2. Collection of survival information using the Pediatric Quality of Life Inventory 4.0 (PedsQl v4.0) in children and adolescents with chronic, advanced heart failure (defined by NYHA Functional Classification).

    Time frame: Within 30 days of CRT implant to 12 months post implant

    Composed of 23 items comprising 4 dimensions. 5-point Likert scale from: 0 (Never) to 4 (Almost always).

    Higher scores = Better health related quality of life (HRQOL)

Secondary outcomes

  1. Echocardiographic measurement predictors of positive response to cardiac resynchronization therapy (CRT) in children and adolescent patients according to the American Society of Echocardiography guidelines

    Time frame: Within 30 days of CRT implant to 12 months post implant

    Describe the relationship between echocardiographic measures and subject response to CRT

Sponsors and collaborators

Lead sponsor

University of Utah

Other

Registry information

Official study title

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

Important dates

Study start
2006
Primary completion
2008
Study completion
2016
First posted
Jan 3, 2008
Registry last updated
May 11, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.