Study Stopped
50cc TAH-t received FDA approval March 5, 2020.
Syncardia 50cc TAH-t as a Bridge to Transplant
SynCardia 50cc Temporary Total Artificial Heart (TAH-t) as a Bridge to Transplant
1 other identifier
interventional
16
1 country
26
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Oct 2015
Longer than P75 for not_applicable
26 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 4, 2014
CompletedFirst Posted
Study publicly available on registry
June 1, 2015
CompletedStudy Start
First participant enrolled
October 1, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 29, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
July 29, 2020
CompletedAugust 10, 2020
August 1, 2020
4.8 years
December 4, 2014
August 6, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Probable Benefit (for Pediatric Arm); Efficacy (for Adult Arm)
Probable benefit will be measured at six months post-implant as either transplanted during the first six months, or continuing on support at six months on the same 50cc TAH-t, without experiencing permanent disabling stroke-related deficits.
6 months
Secondary Outcomes (1)
Safety: Performance Goal of Four Adverse Event Categories
Six months
Study Arms (3)
Primary Pediatric Arm
EXPERIMENTALCardiac transplant-eligible pediatric patients at imminent risk of death from biventricular failure who are 10 - 18 years old at time of TAH-t implant. The intervention is implantation with the 50cc temporary Total Artificial Heart as a bridge to transplantation.
Primary Adult Arm
EXPERIMENTALCardiac transplant-eligible adult patients at imminent risk of death from biventricular failure who are 19 - 75 years old at time of TAH-t implant. The intervention is implantation with the 50cc temporary Total Artificial Heart as a bridge to transplantation.
Secondary Arm
EXPERIMENTALCardiac transplant-eligible pediatric and adult patients at imminent risk of death from biventricular failure who do not meet enrollment criteria for a Primary Arm, but meet less restrictive enrollment criteria for the Secondary Arm. The intervention is implantation with the 50cc temporary Total Artificial Heart as a bridge to transplantation.
Interventions
Replacement of both ventricles and all four valves with the investigational device as a bridge to transplantation.
Eligibility Criteria
You may qualify if:
- At imminent risk of death from biventricular heart failure
- Aged 10 - 18 years (pediatric); 19 - 75 years (adults) at time of implant
- With two functional atrioventricular (A-V) valves
- 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
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
- 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
- Patients who are not cardiac transplant-eligible
- Cardiac transplant-eligible patients
- +3 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (26)
Banner University Medical Center
Tucson, Arizona, 85724, United States
Cedars-Sinai Medical Center
Los Angeles, California, 90048, United States
University of California Los Angeles
Los Angeles, California, 90095, United States
Shands Hospital at the University of Florida
Gainesville, Florida, 32610, United States
Indiana University Health
Indianapolis, Indiana, 46202, United States
Riley Hospital for Children at Indiana University Health
Indianapolis, Indiana, 46202, United States
University of Louisville
Louisville, Kentucky, 40202, United States
Ochsner Medical Center
New Orleans, Louisiana, 70121, United States
Strong Memorial Hospital - Paul Yu Heart Center
Rochester, New York, 14642, United States
Cincinnati Children's Hospital
Cincinnati, Ohio, 45229, United States
The Ohio State University
Columbus, Ohio, 43210, United States
Integris Baptist Medical Center
Oklahoma City, Oklahoma, 73112, United States
The Milton S Hershey Medical Center
Hershey, Pennsylvania, 17033, United States
The Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104, United States
Thomas Jefferson University Hospital
Philadelphia, Pennsylvania, 19107, United States
Children's Health of Dallas
Dallas, Texas, 75235, United States
Baylor University Medical Center at Dallas
Dallas, Texas, 75246, United States
Memorial Hermann Hospital
Houston, Texas, 77030, United States
Methodist DeBakey Heart and Vascular Center
Houston, Texas, 77030, United States
University of Virginia Medical Center
Charlottesville, Virginia, 22903, United States
Virginia Commonwealth University
Richmond, Virginia, 90048, United States
University of Washington Medical Center
Seattle, Washington, 98195, United States
Providence Sacred Heart Medical Center
Spokane, Washington, 99204, United States
Aurora St. Luke's Hospital
Milwaukee, Wisconsin, 53215, United States
Children's Hospital of Wisconsin
Milwaukee, Wisconsin, 53226, United States
Froedtert & the Medical College of Wisconsin
Milwaukee, Wisconsin, 53226, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
David Morales, MD
Children's Hospital Medical Center, Cincinnati
- PRINCIPAL INVESTIGATOR
Francisco Arabia, MD
Cardiac-Dynamics
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 4, 2014
First Posted
June 1, 2015
Study Start
October 1, 2015
Primary Completion
July 29, 2020
Study Completion
July 29, 2020
Last Updated
August 10, 2020
Record last verified: 2020-08