|
General |
Study Status |
Terminated |
Application Number / Requirement Number |
H030003 / PAS001 |
Date Original Protocol Accepted |
02/25/2004
|
Date Current Protocol Accepted |
10/01/2010
|
Study Name |
HeartAssist 5 Pediatric VAD
|
Device Name |
DEBAKEY VAD CHILD VENTRICULAR ASSIST DEVICE SYSTEM
|
General Study Protocol Parameters |
Study Design |
Prospective Cohort Study
|
Data Source |
New Data Collection
|
Comparison Group |
No Control
|
Analysis Type |
Descriptive
|
Study Population |
Child: 2-12 yrs,
Adolescent: 13-18 yrs
|
Detailed Study Protocol Parameters |
Study Objectives |
This study is a prospective non-randomized single-armed registry study of pediatric patients implanted with the DeBakey VAD Child device.
|
Study Population |
Pediatric patients (5-16 years old, with body surface areas >= 0.7m2 and <= 1.5m2). Indication: For patients who are in New York Heart Association Class IV end-stage heart failure, refractory to medical therapy and who are listed as candidates for cardiac transplant.
|
Sample Size |
50 patients, the number of sites were not specified
|
Key Study Endpoints |
Data collected for the registry will be taken from measurements routinely assessed in children with life threatening congestive heart failure. Baseline parameters to be assessed will include demographics, medical history (e.g. ventilator, dialysis, ionotropic, or antiplatelet support, echocardiographic and catheterization assessments, etc). At the time of implant, pump parameters, adverse events, etc will be documented. During support (i.e. post DeBakey VAD Child implantation), data will be collected at week 1 and months 1, 3 and 6. Parameters that will be assessed include pump operation, quality of life (PedsQL), neurological exam, echocardiography, hemodynamics (on POD 3 and on day of catheter removal). Data will also be collected at the time of explant and death (pump parameters and cause of death).
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Follow-up Visits and Length of Follow-up |
After device implantation, patient functional assessment (quality of life, neurological and cardiac) and device performance will be assessed 1, 3 and 6 months post implant and at anytime after a neurological event.
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