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General |
Study Status |
Other |
Application Number / Requirement Number |
H040006 / PAS001 |
Date Original Protocol Accepted |
09/05/2006
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Date Current Protocol Accepted |
09/05/2006
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Study Name |
Abiocor Artificial Heart
|
Device Name |
ABIOCOR IMPLANTABLE REPLACEMENT HEART
|
General Study Protocol Parameters |
Study Design |
Prospective Cohort Study
|
Data Source |
New Data Collection
|
Comparison Group |
No Control
|
Analysis Type |
Descriptive
|
Study Population |
Transit. Adolescent B (as adults) : 18-21 yrs,
Adult: >21
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Detailed Study Protocol Parameters |
Study Objectives |
This is a prospective multi-center single armed study. The goal of the study is to continue to gather clinical data on the AbioCor to permit the continued assessment of its clinical performance while in clinical use.
|
Study Population |
Study Population: Patients in severe biventricular heart failure and who are not transplant candidates; not supportable by a left ventricular assist device alone; are less than 75 years old; require multiple inotropic support; not treatable by left ventricular assist device destination therapy; not weanable from biventricular support, if applicable. Indication: Biventricular heart failure.
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Sample Size |
25 patients, 10 sites
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Key Study Endpoints |
The following outcomes will be assessed: 1) Adverse events: including neurologic events, infection, bleeding, renal dysfunction, liver dysfunction, thrombosis, and respiratory events, 2) Quality of life using the Kansas City Cardiomyopathy Questionnaire and the EuroQol will be administered on a monthly basis while in the hospital and every three months after discharge from the hospital, 3) Characterization of patient activity and interaction with family will be monitored by the patient caregiver, 4) CVA events due to thromboembolism, 5) Discharge history to hotel, intermediary facility, or home, and readmission to hospital, 6) Functional status instruments, including distance walked and ventilatory oxygen uptake measurements, and 7) Neurological assessment, including NIH stroke scale, modified Rankin scale, and a battery of cognitive function tests
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Follow-up Visits and Length of Follow-up |
Post-discharge, patients will be contacted every three months. Patients will be followed until death (while on the device) or other outcome (e.g. elective termination by family, device malfunction, etc).
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