Biventricular Heart Failure Clinical Trial
— RA-540Official title:
SynCardia 70cc Temporary Total Artificial Heart (TAH-t) for Destination Therapy (DT)
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 happen) death from irreversible biventricular heart failure. The purpose of this research study is to evaluate whether the TAH-t can support patients with life-threatening irreversible biventricular heart failure who are not eligible for transplantation. The TAH-t, when used for patients who are not eligible for transplant, is considered to be an investigational (not approved by FDA) use. This use is called destination therapy (DT). Nineteen (19) patients with life-threatening, biventricular failure who are not eligible for cardiac transplant will be enrolled in the Primary Arm of the study and followed for up to six months post-TAH-t implant. Safety will be evaluated by reviewing the adverse events that are experienced by the enrolled subjects and comparing them to previous experience of TAH-t patients who were waiting for a heart transplant. Since approximately 74% of patients with this condition would not be expected to live beyond six months, the benefit of the TAH-t for DT will be confirmed based on survival to six months without experiencing permanent disabling stroke-related deficits. After the six month follow-up visit, patients will continue to be followed under the study for up to five (5) years postTAH-t implant [every six months for up to two years while supported with the TAH-t implant and then annually for another three years]. Up to an additional 19 patients may be enrolled in the Secondary Arm of the study to further characterize the use of the TAH-t for DT in a broader patient population. Follow-up would be the same for patients enrolled in both arms of the study.
| Status | Recruiting |
| Enrollment | 38 |
| Est. completion date | May 2022 |
| Est. primary completion date | December 2021 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 19 Years and older |
| Eligibility | 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) |
| Country | Name | City | State |
|---|---|---|---|
| United States | Memorial Hermann Hospital | Houston | Texas |
| United States | Cedars-Sinai Medical Center | Los Angeles | California |
| United States | Froedtert & the Medical College of Wisconsin | Milwaukee | Wisconsin |
| United States | Integris Baptist Medical Center | Oklahoma City | Oklahoma |
| United States | Banner University Medical Center Phoenix | Phoenix | Arizona |
| United States | Virginia Commonwealth University | Richmond | Virginia |
| United States | Banner University Medical Center | Tucson | Arizona |
| Lead Sponsor | Collaborator |
|---|---|
| SynCardia Systems. LLC |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Probable Benefit | Alive on original TAH-t and free from permanent disabling stroke-related deficits (as evidenced by Modified Rankin Scale score of 0 - 2) at six months post-implant (or transplanted prior to six months post-implant). | Six Months | |
| Secondary | Safety | Adverse Events (AEs) will be captured according to the Intermacs Registry AE definitions and will be assessed according to the same data collection schedule followed under the Intermacs Registry protocol for up to two years post-implant. In addition to reporting of rate, number and percent of subjects experiencing each adverse event, individual performance goals have been determined for four adverse event categories, based on the previous experience of patients supported by the TAH-t while awaiting cardiac transplant. | Six Months |