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| General |
| Study Status |
Delayed |
Application Number /
Requirement Number |
P030011 S011/ PAS003 |
| Date Original Protocol Accepted |
06/25/2025
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| Date Current Protocol Accepted |
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| Study Name |
Companion 2 Driver System PAS
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| Device Name |
SYNCARDIA TEMPORARY TOTAL ARTIFICIAL HEART (TAH-T) SYSTEM
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| Clinical Trial Number(s) |
NCT00614510
NCT00733447
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| General Study Protocol Parameters |
| Study Design |
Prospective Cohort Study
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| Data Source |
External Registry
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| Comparison Group |
No Control
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| Analysis Type |
Descriptive
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| Study Population |
Adult: >21
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| Detailed Study Protocol Parameters |
| Study Objectives |
The Post-Approval Study is a registry-based, multi-center, prospective, new enrollment of all comers. It will provide a confirmatory assessment of both short-term and long-term safety and effectiveness of the 50cc SynCardia temporary Total Artificial Heart (TAH-t) is a post- approval setting.
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| Study Population |
The patient whose de-identified data will be used in this study will be representative of the patient population with irreversible biventricular failure at imminent risk of death and extends across all subpopulations that were implanted with the TAH-t for the following indication: The TAH-t System is indicated for use as a bridge to transplantation in cardia transplant-eligible candidates at risk of imminent death from biventricular failure.
Inclusion Criteria
All patients greater than or equal to 19 years of age who receive a legally utilized MCSD implanted at an INTERMACs – activated center. (NOTE: Patients implanted before the cetner activation data are not eligible for participation in INTERMACS.)
Exclusion Criteria
4. Patients who receive a MCSD, which is not legally utilized
5. Patients who are < 19 years of age
6. Patients who are incarcerated persons (prisoners).
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| Sample Size |
Number of subjects: 24
Assumptions for sample size estimation:
Number of sites: All sites participating in the SYS INTERMACS/PEDIMACS Registry will be eligible to participate in the study.
Sites location: All sites are US.
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| Key Study Endpoints |
Safety Endpoints
Primary:
• Survival outcome (being alive and continuing TAH-t support or having received a transplant).
• Rate of stroke through three-months, six-months and two-years.
Secondary:
• Rates of device malfunction (pump and driver) and rates of adverse events
Effectiveness Endpoints
Primary:
• Time on device (implant to outcome)
Secondary:
• Rates of device exchange (pump and driver, other than for routine schedule service)
Note: TAH malfunctions (device failures) will be documented, investigated, and reported under applicable regulatory requirements, as necessary.
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| Follow-up Visits and Length of Follow-up |
TAH-t patients are followed according to the STS INTERMACS/PEDIMACS Registry Protocol at:
• One week
• One month
• Three months, and
• Six months post-implant and
Will continue to be followed every six months thereafter until 2 years post implant if the patient remains on TAH-t support.
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