Syncardia 50cc TAH-t as a Bridge to Transplant

Cardiac Failure Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02459054
• Other study ID #: RA-551
• Status: Terminated
• Phase: N/A
• Start date: October 2015
• Est. completion date: July 29, 2020

Study information

• Verified date: August 2020
• Source: SynCardia Systems. LLC
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

Heart failure is the reduced ability of the native heart to pump blood and maintain normal bodily function. Heart transplantation is the standard of care treatment for end-stage heart failure but the supply of donor hearts is insufficient to meet the need and many patients are not eligible for transplantation because of age or comorbid conditions.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 16
• Est. completion date: July 29, 2020
• Est. primary completion date: July 29, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 10 Years and older

Eligibility

Inclusion Criteria (Primary Pediatric and Adult Arms):

• 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

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Cardiac Failure
• Heart Failure
• Heart Failure, Left-Sided
• Heart Failure, Right-Sided

Intervention

Device:
• 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.

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
SynCardia Systems. LLC

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Safety: Performance Goal of Four Adverse Event Categories	Safety will be measured by comparison of rate of occurrence of Major infection (sepsis), Neurological event (CVA), Chronic renal dysfunction, and Major device failures/malfunctions against individual performance goals (based on prior 70cc TAH-t experience).	Six months