Syncardia 50cc TAH-t as a Bridge to Transplant

Stopped early · Not applicable

Conditions studied: Heart Failure, Right-Sided, Cardiac Failure, Heart Failure, Left-Sided

In brief

The primary objective of the study is to evaluate whether the 50cc TAH-t can safely support, and provide probable benefit to, transplant-eligible pediatric patients (aged 10 - 18 years) and can safely and effectively support transplant-eligible adult patients (aged 19 - 75 years) at imminent risk of death from biventricular failure without experiencing permanent disabling, stroke-related deficits. The study will be conducted as a three-arm trial of the 50cc temporary Total Artificial Heart (TAH-t) as a bridge to transplant: * The Primary Pediatric Arm of the trial will evaluate the safety and probable benefit of the 50cc TAH-t for transplant-eligible patients 10 through 18 years of age. * The Primary Adult Arm of the trial will evaluate the safety and efficacy of the 50cc TAH-t for transplant-eligible patients 19 through 75 years of age. * The Secondary Arm will capture pediatric and adult subjects who did not meet enrollment criteria for a Primary Arm, but meet the less restrictive Secondary Arm enrollment criteria, in order to further characterize the use of the device.

Key facts

Study ID: NCT02459054
Run by: SynCardia Systems. LLC
People needed: 16
Starts: 2015-10-01
Expected to finish: 2020-07-29
Last updated by the study team: 2020-08-10

Who can join

Age: 10 and older. Sex: any. Healthy volunteers: not accepted.

You may not qualify if…

Patients who are not cardiac transplant-eligible
Cardiac transplant-eligible patients
Who cannot be adequately anticoagulated on the TAH-t
With insufficient space in the chest
Who are on extracorporeal membrane oxygenation (ECMO) support > 3 days
Patients who are being supported by an investigational device at the time of evaluation for a 50cc TAH-t
Patients who have required cardiopulmonary resuscitation (CPR) for > 30 minutes within 14 days prior to proposed implant
Patients who have experienced a stroke within 30 days prior to proposed implant
Patients who are dialysis-dependent at time of proposed implant
Inclusion Criteria, Secondary Arm (pediatric and adult patients)
Not eligible for Primary Arm
At imminent risk of death from biventricular heart failure
With Body Surface Area (BSA) of 1.2 through 1.85m2
With adequate sternum to T10 distance OR Adequate room in chest as determined by 3-D imaging assessment or by other standard clinical assessments
Exclusion Criteria, Secondary Arm:
Patients who are not cardiac transplant-eligible
Cardiac transplant-eligible patients
Who cannot be adequately anticoagulated on the TAH-t
With insufficient space in the chest
Patients who are being supported by an investigational device at the time of evaluation for a 50cc TAH-t

Where it is running

Banner University Medical Center — Tucson, Arizona, United States
Cedars-Sinai Medical Center — Los Angeles, California, United States
University of California Los Angeles — Los Angeles, California, United States
Shands Hospital at the University of Florida — Gainesville, Florida, United States
Indiana University Health — Indianapolis, Indiana, United States
Riley Hospital for Children at Indiana University Health — Indianapolis, Indiana, United States
University of Louisville — Louisville, Kentucky, United States
Ochsner Medical Center — New Orleans, Louisiana, United States
Strong Memorial Hospital - Paul Yu Heart Center — Rochester, New York, United States
Cincinnati Children's Hospital — Cincinnati, Ohio, United States
The Ohio State University — Columbus, Ohio, United States
Integris Baptist Medical Center — Oklahoma City, Oklahoma, United States
The Milton S Hershey Medical Center — Hershey, Pennsylvania, United States
The Children's Hospital of Philadelphia — Philadelphia, Pennsylvania, United States
Thomas Jefferson University Hospital — Philadelphia, Pennsylvania, United States
Children's Health of Dallas — Dallas, Texas, United States
Baylor University Medical Center at Dallas — Dallas, Texas, United States
Memorial Hermann Hospital — Houston, Texas, United States
Methodist DeBakey Heart and Vascular Center — Houston, Texas, United States
University of Virginia Medical Center — Charlottesville, Virginia, United States
Virginia Commonwealth University — Richmond, Virginia, United States
University of Washington Medical Center — Seattle, Washington, United States
Providence Sacred Heart Medical Center — Spokane, Washington, United States
Aurora St. Luke's Hospital — Milwaukee, Wisconsin, United States
Children's Hospital of Wisconsin — Milwaukee, Wisconsin, United States

Full record on ClinicalTrials.gov

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