SynCardia Companion 2 Driver System Post Approval Study Protocol With INTERMACS™-Based Data Collection (C2 PAS)

Syncardia

Status: Unknown

Conditions: Bi-ventricular Failure

Treatments: Device: CSS Console TAH-t Patients; Device: C2 Driver System TAH-t Patients

Study type: Observational

Funder types: Industry

Identifiers

NCT01919320

Data Collection via INTERMACS (Registry Identifier)

RA-409

Details and patient eligibility

About

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.

Enrollment: 500 estimated patients

Sex: All

Volunteers: No Healthy Volunteers

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.

Trial design

500 participants in 3 patient groups

CSS Console TAH-t Patients

Description:

All TAH-t patients implanted while supported with the CSS Console who were enrolled in the INTERMACS Registry and implanted with the TAH-t on or after June 20, 2012.

Treatment:

Device: CSS Console TAH-t Patients

C2 Driver System TAH-t Patients

Description:

200 TAH-t patients implanted while supported by the Companion 2 (C2) Driver System who were enrolled in the INTERMACS Registry and implanted with the TAH-t on or after June 20, 2012.

Treatment:

Device: C2 Driver System TAH-t Patients

All TAH-t Patient Records

Description:

All records for TAH-t patients enrolled in the INTERMACS Registry will be reviewed to support Objective 2 of the protocol.

Treatment:

Device: C2 Driver System TAH-t Patients

Device: CSS Console TAH-t Patients