CRT Pilot Study for Children With Heart Failure

University of Utah7 enrolled

Overview

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 Type

OBSERVATIONAL

Enrollment

Conditions

Chronic Pediatric Heart Failure

Interventions

CRT device implantDEVICE

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.

Eligibility

Sex: ALLMin age: 1 YearMax age: 18 Years

Medical Language ↔ Plain English

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.

Locations (1)

University of Utah

Salt Lake City, Utah, United States

Outcomes

Primary Outcomes

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)

Time frame: 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)

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

Secondary Outcomes

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

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

Data from ClinicalTrials.gov

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