CRT Pilot Study for Children With Heart Failure

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

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

Study Overview

• Status: Completed
• Conditions: Chronic Pediatric Heart Failure
• Intervention / Treatment: Device: CRT device implant

• Study Type: Observational
• Enrollment (Actual): 7

Contacts and Locations

Study Locations

• United States
  • Utah
    • Salt Lake City, Utah, United States, 84112
      • University of Utah

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 year to 18 years (Child, Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

Primary care clinic

Description

Inclusion Criteria:

1. Chronic and severe heart failure, NYHA class III or IV
2. Patients optimized and stable on diuretics and afterload reducing agents (with or without inotropes) for at least 1 week prior to enrollment
3. Chronic systemic ventricular dysfunction as defined in the protocol.
4. Intra ventricular conduction delay defined by spontaneous QRS duration > ULN for age.
5. All children from 1 to 18 years of age, both male and female, and all ethnic backgrounds.
6. Signed and dated informed consent.
7. Able to receive pectoral or abdominal implant.

Exclusion criteria:

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

Pediatric and adolescent patients receiving CRT with BVP for treating chronic heart failure; Pediatric and adolescent patients who are receiving cardiac resynchronization therapy with biventricular pacing as a method of treating chronic heart failure. Children of both genders, who are followed in the Division of Pediatric Cardiology at Primary Children's Medical Center, who meet all inclusion and no exclusion criteria are eligible for participation in this clinical study. No intervention is administered as part of this study. Prospective longitudinal case series study to describe and evaluate clinical and hemodynamic effects of CRT and to identify echocardiographic predictors of positive response to CRT in Group described.

Device: CRT device implant; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	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)	Within 30 days of CRT implant to 12 months post implant
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).	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)	Within 30 days of CRT implant to 12 months post implant

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Echocardiographic measurement predictors of positive response to cardiac resynchronization therapy (CRT) in children and adolescent patients according to the American Society of Echocardiography guidelines	Describe the relationship between echocardiographic measures and subject response to CRT	Within 30 days of CRT implant to 12 months post implant

Collaborators and Investigators

• Sponsor: University of Utah
• Investigators: Principal Investigator: Elizabeth Saarel, MD, University of Utah

Study record dates

Study Major Dates

• Study Start: January 1, 2006
• Primary Completion (Actual): January 1, 2008
• Study Completion (Actual): January 1, 2016

Study Registration Dates

• First Submitted: December 21, 2007
• First Submitted That Met QC Criteria: January 2, 2008
• First Posted (Estimate): January 3, 2008

Study Record Updates

• Last Update Posted (Estimate): May 11, 2023
• Last Update Submitted That Met QC Criteria: May 8, 2023
• Last Verified: April 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Heart Failure
• Other Study ID Numbers: 00015291; IRB#: 00015291

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes