Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 2:55 PM
Ignite Modification Date:
2025-12-24 @ 2:55 PM
NCT ID:
NCT02232659
Eligibility Criteria:
Primary Arm
Inclusion Criteria:
1. Patients with ife-threatening, irreversible biventricular heart failure (Intermacs Patient Profile Classifications 1 - 4)
2. 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.
3. On optimal medical management and failing to respond or failing DT VAD therapy (continuing to decline)
4. Ambulatory without assistance
5. Patients between 19 and 75 years of age
6. Patients with Body Surface Area (BSA) of ≥ 1.7m2
7. Sternum to T10 distance \> 10cm OR adequate room in chest as determined by 3-D imaging assessment or by other standard clinical assessments
Exclusion Criteria:
1. Cardiac transplant-eligible patients
2. Patients who cannot be adequately anticoagulated on the TAH-t
3. Patients with insufficient space in the chest
4. Patients on ECMO support
5. Patients with Cirrhosis (evidenced by ultrasound, CT scan, or positive biopsy)
6. Patients with Acute or Chronic Renal dysfunction (per Intermacs AE Definitions)
7. Patients with cardiac cachexia (e.g., pre-albumin \<17, fragility, and catabolic/anabolic imbalance)
8. Patients with a comorbidity that has a poor prognosis of survival beyond six months
9. Patients with insufficient social support or who have demonstrated non-compliance with medical instructions (as determined by the Principal Investigator)
Secondary Arm
Inclusion Criteria:
1. Patients who are NOT eligible to participate in the Primary Arm
2. Patients with life-threatening, irreversible biventricular heart failure (Intermacs Patient Profile Classifications 1 - 7)
3. Ineligible for cardiac transplantation (as determined by the implanting center at time of implant screening assessment).
4. On optimal medical management and failing to respond or failing DT VAD therapy (continuing to decline)
5. Patients 19 years of age or older
6. Sternum to T10 distance \> 10cm OR adequate room in chest as determined by 3-D imaging assessment or by other standard clinical assessments
Exclusion Criteria:
1. Patients who are less than 19 years old
2. Cardiac transplant-eligible patients
3. Patients with Cirrhosis (evidenced by ultrasound, CT scan, or positive biopsy)
4. Patients with Chronic Renal dysfunction (per Intermacs AE Definitions)
5. Patients with insufficient space in the chest
6. Patients who cannot be adequately anticoagulated on the TAH-t
7. Patients with insufficient social support or who have demonstrated non-compliance with medical instructions (as determined by the Principal Investigator)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
19 Years
Study:
NCT02232659
Study Brief:
Protocol Section:
NCT02232659