Chronic Pediatric Heart Failure
Conditions
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.
Interventions
DEVICECRT 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.
Sponsors
University of Utah
Study design
Observational model
OTHER
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
1 Years to 18 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
United States
Outcome results
None listed