SynCardia 50cc Temporary Total Artificial Heart (TAH-t) as a Bridge to Transplant

Status: Terminated
Location: See all (26) locations...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 10
Healthy Volunteers: No
View:

• 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

• 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

Locations
United States
Arizona
Banner University Medical Center
Tucson
California
Cedars-Sinai Medical Center
Los Angeles
University of California Los Angeles
Los Angeles
Florida
Shands Hospital at the University of Florida
Gainesville
Indiana
Indiana University Health
Indianapolis
Riley Hospital for Children at Indiana University Health
Indianapolis
Kentucky
University of Louisville
Louisville
Louisiana
Ochsner Medical Center
New Orleans
New York
Strong Memorial Hospital - Paul Yu Heart Center
Rochester
Ohio
Cincinnati Children's Hospital
Cincinnati
The Ohio State University
Columbus
Oklahoma
Integris Baptist Medical Center
Oklahoma City
Pennsylvania
The Milton S Hershey Medical Center
Hershey
The Children's Hospital of Philadelphia
Philadelphia
Thomas Jefferson University Hospital
Philadelphia
Texas
Baylor University Medical Center at Dallas
Dallas
Children's Health of Dallas
Dallas
Memorial Hermann Hospital
Houston
Methodist DeBakey Heart and Vascular Center
Houston
Virginia
University of Virginia Medical Center
Charlottesville
Virginia Commonwealth University
Richmond
Washington
University of Washington Medical Center
Seattle
Providence Sacred Heart Medical Center
Spokane
Wisconsin
Aurora St. Luke's Hospital
Milwaukee
Children's Hospital of Wisconsin
Milwaukee
Froedtert & the Medical College of Wisconsin
Milwaukee
Time Frame
Start Date: October 2015
Completion Date: July 29, 2020
Participants
Target number of participants: 16
Treatments
Experimental: 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.
Experimental: 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.
Experimental: 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.
Related Therapeutic Areas
Sponsors
Leads: SynCardia Systems. LLC

This content was sourced from clinicaltrials.gov

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