Cardiac Failure Clinical Trial
Official title:
SynCardia 50cc Temporary Total Artificial Heart (TAH-t) as a Bridge to Transplant
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.
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.
;
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT03799133 -
Safety and Efficacy of the Gastric Reactance (XL) in Patients Post-operated of Elective Cardiac Surgery
|
N/A | |
Not yet recruiting |
NCT04538469 -
Absent Visitors: The Wider Implications of COVID-19 on Non-COVID Cardiothoracic ICU Patients, Relatives and Staff
|
||
Terminated |
NCT02205411 -
Clinical Trial to Evaluate the the ReliantHeart HeartAssist 5® VAD System in Patients Awaiting Heart Transplantation
|
N/A | |
Completed |
NCT02524574 -
Tomography Positron Emission Assessment of the Impact of Cardiac Rehabilitation on Coronary Endothelial Function in Cardiac Failure
|
N/A | |
Active, not recruiting |
NCT03841084 -
Blend to Limit Oxygen in ECMO: A Randomised Controlled Registry Trial
|
Phase 2 | |
Terminated |
NCT02859636 -
Pronostic Value of Endothelial Dysfunction in Heart Failure
|
N/A | |
Completed |
NCT04599816 -
Levosimendan Administration in Pulmonary Hypertension
|
N/A | |
Recruiting |
NCT05761639 -
Physical Exercise and Telephone Follow-up Mediated by Telerehabilitation
|
N/A | |
Not yet recruiting |
NCT04696523 -
Effect of Xenon on Brain Injury After Aneurysmal Subarachnoid Hemorrhage
|
Phase 2 | |
Completed |
NCT03357731 -
A Study of Continuous Infusions of HNO (Nitroxyl) Donor in Patients With Heart Failure and Impaired Systolic Function
|
Phase 2 | |
Completed |
NCT02331264 -
Cardiac Assessment of Patients With Hip Implants
|
N/A | |
Terminated |
NCT01921829 -
Protocolized Diuretic Strategy in Cardiorenal Failure
|
Phase 4 | |
Completed |
NCT06197256 -
Cardiac Dysfunction in Critically Ill Covid-19 Patients
|
||
Recruiting |
NCT03197792 -
Perioperative Portal Vein Pulsatility as a Postoperative Prognostic Indicator in Pulmonary Endarterectomy
|
N/A | |
Completed |
NCT03515980 -
An Investigational Study of Experimental Medication BMS-986231 Given in Participants With Different Levels of Liver Function
|
Phase 1 | |
Completed |
NCT03212898 -
Pharmacist Interventions in Rural Elderly Warfarin Patients
|
N/A | |
Completed |
NCT03243604 -
cARdiotoxicity Profile of aBIraTeRone in prostAte Cancer : a pharmacoviGilancE Study
|
||
Completed |
NCT06330103 -
Efficacy of AI EF Screening by Using Smartphone Application Recorded PLAX View Cardiac Ultrasound Video Clips
|
N/A | |
Completed |
NCT02660385 -
Insomnia Self-Management in Heart Failure
|
N/A | |
Withdrawn |
NCT02669134 -
CRT Improved Clinical Response UK Trial
|
Phase 3 |