Clinical trial NCT01919320: SynCardia Companion 2 Driver System Post Approval Study Protocol With INTERMACS™-Based Data Collection
Official title: SynCardia Companion 2 Driver System Post Approval Study Protocol With INTERMACS™-Based Data Collection
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Bi-ventricular Failure
Keywords: SynCardia
Total Artificial Heart
TAH-t
Lead sponsor: SynCardia Systems. LLC
Sponsor class: INDUSTRY
First posted: 2013-08-09
Enrollment: 500
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with bi-ventricular failure at risk of imminent death who are implanted with the SynCardia temporary Total Artificial Heart (TAH-t) AND who have enrolled in the INTERMACS Registry

Brief summary: Study Purpose

The purpose of this PAS is to confirm that patients implanted with the temporary Total Artificial Heart (TAH-t) and supported with the Companion 2 Driver System have outcomes similar to those patients implanted with the TAH-t and supported with the CSS Console. The data collection mechanism for this study is the INTERMACS Registry.

Study Objectives

Primary Objective 1:

To confirm that patients implanted with the TAH-t and supported by the Companion 2 Driver System have outcomes similar to those patients implanted with the TAH-t and supported by the CSS Console.

Primary Objective 2:

To compare positive outcome rates for all TAH-t patients entered in the Intermacs Registry initially supported with the Companion 2 Driver System to positive outcome rates for all TAH-t patients initially supported by the CSS Console.

Primary Objective 3:

To review additional data (patient survival, adverse event rates and bridge to transplant rates) to support the conclusion that the use of an artificial heart is reasonable and necessary for the treatment of irreversible biventricular failure in Medicare/Medicaid patients.

Secondary Objective:

* To evaluate the incidence of adverse events (AEs). The AEs will follow the definitions in the INTERMACS Registry.

Study Hypothesis: Primary Objective 1 The primary hypothesis is that the positive outcome rate (defined as transplant , transfer to the Freedom Driver System support, or continuing on implant driver support, whichever occurs first; assessed at three and six months post-implant) for patients supported with the Companion 2 Driver System is non-inferior to the survival rate for patients supported with the Circulatory Support System (CSS) Console.

Data Collection The data will be collected as defined in the INTERMACS Protocol and the patients will be followed at one week, one month, three months and six months or until their study endpoint is reached.

Data Analysis

Primary Objective 1:

Data analysis will provide descriptive statistics on enrollment, adverse events, and outcomes for TAH-t patients who were implanted while supported with the Companion 2 Driver System compared to TAH-t patients who were implanted while supported with the CSS Console.

Primary Objective 2:

Data analysis will provide descriptive statistics on enrollment, adverse events, and outcomes for all TAH-t patients enrolled in the INTERMACS Registry.

Phase I as described above was completed; Phase II of Study design is under review by FDA with anticipated initiation in early 2021.


Eligibility criteria: Inclusion Criteria:

* Implanted with the TAH-t
* Patient or their legal representative has signed an informed consent (ICF) form for INTERMACS Registry participation or waiver of consent has been approved at the implanting institution.

Exclusion Criteria:

* Patient or legal guardian has not signed an ICF for INTERMACS Registry participation, if required at the institution.
* Patient is incarcerated.

Primary outcomes:
measure: Positive outcome rates at three months and six months Post TAH-t Implant (Concurrent Cohort)
timeFrame: Three and Six Months Post-TAH-t Implant
measure: Positive outcome rates at three months and six months Post TAH-t Implant (Cumulative Cohort)
timeFrame: Three and Six Months Post-TAH-t Implant
Secondary outcomes:
measure: Review of all TAH-t patient records in the INTERMACS Registry to confirm acceptability of treatment for bi-ventricular failure.
timeFrame: Three and Six Months Post-TAH-t Implant
Other outcomes:
measure: Comparison of Adverse Event Rates
timeFrame: Three and Six Months Post-TAH-t Implant or Study Endpoint, whichever occurs first.
Locations:
Study officials:
affiliation: Banner University Medical Center
name: Francisco Arabia, MD
role: PRINCIPAL_INVESTIGATOR
References: