CRT Pilot Study for Children With Heart Failure

Completed

• Conditions: Chronic Pediatric Heart Failure
• Interventions: Device: CRT device implant

• Registration Number: NCT00585065
• Lead Sponsor: University of Utah

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 available

Study Timeline

• Study Start: 2006-01
• Study First Submitted: 2007-12-21
• Primary Completion: 2008-01
• Study First Submitted QC: 2008-01-02
• Study First Posted: 2008-01-03
• Study Completion: 2016-01
• Status Verified: 2021-04
• Last Update Submitted: 2023-05-08
• Last Update Posted: 2023-05-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 7

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.

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Pediatric and adolescent patients receiving CRT with BVP for treating chronic heart failure	CRT device implant	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.

Primary Outcome Measures

Name	Time	Method
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).	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)
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).	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 Outcome Measures

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

Trial Locations

Locations (1)

University of Utah; 🇺🇸 Salt Lake City, Utah, United States