|
General |
Study Status |
Completed |
Application Number / Requirement Number |
P030011 / PAS001 |
Date Original Protocol Accepted |
10/15/2004
|
Date Current Protocol Accepted |
01/04/2011
|
Study Name |
Long Term
|
Device Name |
SYNCARDIA TEMPORARY CARDIO WEST TOTAL ARTIFICIAL HEART (TAH-T)
|
General Study Protocol Parameters |
Study Design |
Prospective Cohort Study
|
Data Source |
Sponsor Registry
|
Comparison Group |
No Control
|
Analysis Type |
Descriptive
|
Study Population |
Adolescent: 13-18 yrs,
Transit. Adolescent A (distinctively) : 18-21 yrs,
Transit. Adolescent B (as adults) : 18-21 yrs,
Adult: >21
|
Detailed Study Protocol Parameters |
Study Objectives |
.Enhanced surveillance of all device usage.
|
Study Population |
No human subjects will be enrolled in this enhanced surveillance of the Companion 2 Driver System Study. The data for this study are being collected under an existing procedure for reporting and assessing Customer Experiences relating to all SynCardia devices being used globally.
|
Sample Size |
This surveillance study will be conducted over one year commencing with the first use of the Companion 2 Driver System after study initiation and continued for one year with no specified sample size. It is anticipated that the Companion 2 Driver System will be used approximately 100 times in the United States during the one year duration of this study.
|
Key Study Endpoints |
1. Number of times the Companion 2 Driver System is used to support a patient during the study period. (Each time a patient is transferred to a Companion 2 Driver System will count as one use.) 2. Number of Customer Experiences related to the Companion 2 Driver System or its accessories submitted during the study period. 3. Number of Customer Experiences related to the Companion 2 Driver system or its accessories that involved human factors submitted during the study period. 4. Types of identified human factors, severity of impact to patient care, and frequency of occurrence, will be calculated across all sites and by individual site.
|
Follow-up Visits and Length of Follow-up |
Not applicable Not applicable
|