Status:
UNKNOWN
SynCardia 70cc TAH-t for Destination Therapy (DT)
Lead Sponsor:
SynCardia Systems. LLC
Conditions:
Life-threatening
Biventricular Heart Failure
Eligibility:
All Genders
19+ years
Phase:
NA
Brief Summary
The SynCardia 70cc temporary Total Artificial Heart (TAH-t) is approved by the U.S. Food and Drug Administration (FDA) for use as a bridge to transplant for patients at risk of imminent (about to happ...
Detailed Description
On 15 October 2004, the SynCardia temporary Total Artificial Heart (TAH-t) received Food and Drug Administration (FDA) approval (Premarket Approval Application \[PMA\] #P030011) for in-hospital use as...
Eligibility Criteria
Inclusion
- Primary Arm
- Patients with ife-threatening, irreversible biventricular heart failure (Intermacs Patient Profile Classifications 1 - 4)
- Ineligible for cardiac transplantation (e.g., contraindication to immunosuppression, cancer, elevated panel reactive antibodies \[PRAs\]) as determined by the implanting center at time of implant screening assessment.
- On optimal medical management and failing to respond or failing DT VAD therapy (continuing to decline)
- Ambulatory without assistance
- Patients between 19 and 75 years of age
- Patients with Body Surface Area (BSA) of ≥ 1.7m2
- Sternum to T10 distance \> 10cm OR adequate room in chest as determined by 3-D imaging assessment or by other standard clinical assessments
Exclusion
- Cardiac transplant-eligible patients
- Patients who cannot be adequately anticoagulated on the TAH-t
- Patients with insufficient space in the chest
- Patients on ECMO support
- Patients with Cirrhosis (evidenced by ultrasound, CT scan, or positive biopsy)
- Patients with Acute or Chronic Renal dysfunction (per Intermacs AE Definitions)
- Patients with cardiac cachexia (e.g., pre-albumin \<17, fragility, and catabolic/anabolic imbalance)
- Patients with a comorbidity that has a poor prognosis of survival beyond six months
- Patients with insufficient social support or who have demonstrated non-compliance with medical instructions (as determined by the Principal Investigator)
- Secondary Arm
- Inclusion Criteria:
- Patients who are NOT eligible to participate in the Primary Arm
- Patients with life-threatening, irreversible biventricular heart failure (Intermacs Patient Profile Classifications 1 - 7)
- Ineligible for cardiac transplantation (as determined by the implanting center at time of implant screening assessment).
- On optimal medical management and failing to respond or failing DT VAD therapy (continuing to decline)
- Patients 19 years of age or older
- Sternum to T10 distance \> 10cm OR adequate room in chest as determined by 3-D imaging assessment or by other standard clinical assessments
Key Trial Info
Start Date :
February 1 2016
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 1 2022
Estimated Enrollment :
38 Patients enrolled
Trial Details
Trial ID
NCT02232659
Start Date
February 1 2016
End Date
May 1 2022
Last Update
March 17 2021
Active Locations (7)
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1
Banner University Medical Center Phoenix
Phoenix, Arizona, United States, 85006
2
Banner University Medical Center
Tucson, Arizona, United States, 85726
3
Cedars-Sinai Medical Center
Los Angeles, California, United States, 90048
4
Integris Baptist Medical Center
Oklahoma City, Oklahoma, United States, 73112