Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
NA
16 participants
INTERVENTIONAL
2015-10-31
2020-07-29
Brief Summary
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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.
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Detailed Description
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On 15 October 2004, the SynCardia 70cc temporary TAH-t System received Food and Drug Administration (FDA) approval for Premarket Approval Application (PMA) #P030011 for in-hospital use as a bridge to transplant (BTT) in cardiac transplant-eligible candidates at risk of imminent death from biventricular failure. The system consists of the implantable TAH-t and an external pneumatic driver. Subsequent to the original approval, two additional external pneumatic drivers have been approved for use with the 70cc TAH-t.
On 30 January 2013, FDA granted a Humanitarian Use Designation (HUD) to the 50cc TAH-t for use as BTT in pediatric patients with biventricular heart failure who have a body surface area (BSA) that can sufficiently accommodate the device. To evaluate the ability of the device to support patients who are too small to be supported with the 70cc TAH-t, SynCardia will conduct a clinical study.
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 the pediatric arm, but meet the less restrictive Secondary Arm enrollment criteria, in order to further characterize the use of the device.
Pediatric subject data through six months post-implant will be reported to FDA to support a Humanitarian Device Exemption (HDE) application for an orphan indication in pediatric patients for which there is no alternative replacement device. Pediatric subjects (enrolled in the Primary Pediatric Arm or Secondary Arm) who are continuing on TAH-t support at the six month study visit will continue to be followed under the study every six months until transplant, withdrawal from the study, all subjects in the respective arm have reached an endpoint, or death, whichever occurs first.
The primary objective of the Primary Pediatric Arm of the study 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. Probable benefit will be measured as transplanted during the first six months, or survival at six months and continuing on support on the initially placed 50cc TAH-t, without experiencing permanent disabling stroke-related deficits.
Safety will be evaluated by the characterization of the adverse event (AE) profile through the six month study end date. AEs will be identified by the terms and definitions of the Pedimacs/Intermacs Registry. The secondary endpoints to establish safety for both the pediatric and adult arms will be measured by performance goals (based on prior experience with the 70cc TAH-t) for the four adverse event categories that are likely to delay or preclude transplant. The four categories are: Major infection (sepsis), Neurological event (CVA), Chronic renal dysfunction, Major device failures/malfunctions per the Pedimacs/Intermacs AE definitions.
Adult patient data through six months post-implant will be reported to FDA to support a Premarket application (PMA) for treatment of small-statured adult patients who are unable to accommodate the 70cc TAH-t in their chest cavity and for whom there is no alternative replacement device. Adult subjects (enrolled in the Primary Adult Arm or the Secondary Arm) will be followed through six months post-implant and, if continuing on support at that time, will continue to be followed under the study every six months until transplant, withdrawal from the study, all subjects in the respective arm have reached an endpoint, or death, whichever occurs first.
Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Primary Pediatric Arm
Cardiac 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.
SynCardia 50cc temporary Total Artificial Heart (TAH-t)
Replacement of both ventricles and all four valves with the investigational device as a bridge to transplantation.
Primary Adult Arm
Cardiac 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.
SynCardia 50cc temporary Total Artificial Heart (TAH-t)
Replacement of both ventricles and all four valves with the investigational device as a bridge to transplantation.
Secondary Arm
Cardiac 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.
SynCardia 50cc temporary Total Artificial Heart (TAH-t)
Replacement of both ventricles and all four valves with the investigational device as a bridge to transplantation.
Interventions
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SynCardia 50cc temporary Total Artificial Heart (TAH-t)
Replacement of both ventricles and all four valves with the investigational device as a bridge to transplantation.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
* 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
* 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
10 Years
ALL
No
Sponsors
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SynCardia Systems. LLC
INDUSTRY
Responsible Party
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Principal Investigators
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David Morales, MD
Role: PRINCIPAL_INVESTIGATOR
Children's Hospital Medical Center, Cincinnati
Francisco Arabia, MD
Role: PRINCIPAL_INVESTIGATOR
Cardiac-Dynamics
Locations
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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
Froedtert & the Medical College of Wisconsin
Milwaukee, Wisconsin, United States
Countries
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Other Identifiers
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RA-551
Identifier Type: -
Identifier Source: org_study_id
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