Below we address some of the common questions we receive about inclusion and exclusion criteria for the FDA clinical trial of the 70cc TAH for Destination Therapy.
Approved as a bridge to transplant by the FDA in 2004, the 70cc temporary Total Artificial Heart (TAH) has been implanted in more than 1,700 patients worldwide, accounting for more than 600 total patient-years of support. In an effort to give more patients access to this life-saving technology, the 70cc TAH is currently undergoing an IDE clinical study with a Primary Arm and a Secondary Arm for use as destination therapy (DT) in adult patients who are not eligible for heart transplantation. Below, we provide answers to some of the common questions we receive from study sites regarding patient eligibility for the trial.
Q: What INTERMACS profile does the patient need to be?
A: Eligibility for the Primary Arm is limited to patients in INTERMACS Registry Patient Profile Classifications 1 – 4. INTERMACS Registry Patient Profile Classifications 1 – 7 are eligible for enrollment in the Secondary Arm.
Q: How do I determine if the patient is a DT candidate?
A: DT designation should not be based on ineligibility for listing at the time of assessment, but on the long-term treatment plan (BTC, BTT or DT).
Q: What does “ambulatory without assistance” mean?
A: The use of a walker or cane is considered ambulatory without assistance, as long as the patient can move without assistance from another individual.
Q: How do I know if the 70cc TAH will fit in the patient?
A: Fit may be determined by standard clinical assessments (e.g., posterior sternum to anterior spine measurement at T10 of >10 cm, LVEDD >70 mm) or 3D imaging assessment (contact SynCardia Clinical Support for assistance).
Q: What if the patient can’t be adequately anticoagulated?
A: The TAH is contraindicated for use in patients who are unable to be adequately anticoagulated.
Q: What if the patient is on ECMO?
A: Patients on ECMO support are ineligible for the Primary Arm, but can be included in the Secondary Arm.
Q: What if the patient has cardiac cachexia?
A: Patients with cardiac cachexia are excluded from the Primary Arm, but are eligible for the Secondary Arm, as determined by the treating physician.
Q: What if the patient lacks social support or has demonstrated non-compliance?
A: Patients with insufficient social support or who have demonstrated non-compliance with medical instructions (as determined by the Principal Investigator) should be excluded from either arm of the study. For DT patients, it is desirable that they be safely discharged to the home environment. Lack of social support or non-compliance with medical instructions could put patients at increased risk in the out-of-hospital environment.