SynCardia 50cc Temporary Total Artificial Heart (TAH-t)for Bridge to Transplant (BTT) Study
Study ID: STU 072015-057
This study is a non-randomized, prospective, multi-center study, with three active treatment arms. one arm will support an HDe application for pediatric patients for which there is no alternative replacement device (Pediatric arm). The second arm will support a PMa for adult patients at risk of imminent death from biventricular failure (adult arm). The third arm is a Secondary arm for transplant-eligible pediatric and adult patients at imminent risk of death from biventricular heart failure who do not otherwise meet all enrollment criteria for one of Primary arms.
Primary Arm - Pediatric (1) Inclusion criteria: Pediatric cardiac transplant-eligible patients: (a) At imminent risk of death from biventricular heart failure (b) Aged 10 x 18 years (at time of implant) (c) With two functional atrioventricular (A-V) valves (d) With Body Surface Area (BSA) of 1.2m2 through 1.85m2 (e) With adequate sternum to T10 distance OR adequate room in chest as determined by 3-D imaging assessment or by other standard clinical assessments
The Primary objective of the study for the pediatric arm is to evaluate whether the 50cc TaH-t can safely support, and provide probable benefit to, transplant-eligible pediatric patients at imminent risk of death from biventricular failure without experiencing permanent disabling, stroke-related deficits as measured by the Pediatric Stroke outcome Measure (PSoM). For those subjects experiencing a stroke, the absence of disabling, stroke-related deficits will be evidenced by a PSoM score of 0 - 2.