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

October 21, 2020 updated by: SynCardia Systems. LLC

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.

Study Overview

Status

Enrolling by invitation

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

500

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Cross-Sectional

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
CSS Console TAH-t Patients
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.
Device: CSS Console TAH-t Patients
Comparison of two pneumatic drivers supporting the SynCardia TAH-t.
Other Names:
  • SynCardia
C2 Driver System TAH-t Patients
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.
Device: C2 Driver System TAH-t Patients
Comparison of two pneumatic drivers supporting the SynCardia TAH-t
Other Names:
  • SynCardia
All TAH-t Patient Records
All records for TAH-t patients enrolled in the INTERMACS Registry will be reviewed to support Objective 2 of the protocol.
Device: CSS Console TAH-t Patients
Comparison of two pneumatic drivers supporting the SynCardia TAH-t.
Other Names:
  • SynCardia
Device: C2 Driver System TAH-t Patients
Comparison of two pneumatic drivers supporting the SynCardia TAH-t
Other Names:
  • SynCardia

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Positive outcome rates at three months and six months Post TAH-t Implant (Concurrent Cohort)
Time Frame: Three and Six Months Post-TAH-t Implant

The positive outcome rates, defined as transplant, transfer to the Freedom Driver System, or continuing on implant driver support (whichever occurs first) for patients implanted on or after June 20, 2012 and supported with the Companion 2 Driver System will be compared to the positive outcome rates at three and six months for patients implanted on or after June 20, 2012 and supported with the Circulatory Support System (CSS) Console.

The analysis will include a lower one-sided 95% confidence bound on the observed survival rate for patients supported with the Companion 2 Driver system which will be compared to the CSS Console survival rate to evaluate non-inferiority.
Three and Six Months Post-TAH-t Implant
Positive outcome rates at three months and six months Post TAH-t Implant (Cumulative Cohort)
Time Frame: Three and Six Months Post-TAH-t Implant

The positive outcome rates, defined as transplant, transfer to the Freedom Driver System, or continuing on implant driver support (whichever occurs first) for patients supported with the Companion 2 Driver System will be compared to the positive outcome rates at three and six months for patients supported with the Circulatory Support System (CSS) Console.

The analysis will include a lower one-sided 95% confidence bound on the observed survival rate for patients supported with the Companion 2 Driver system which will be compared to the CSS Console survival rate to evaluate non-inferiority.
Three and Six Months Post-TAH-t Implant

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Review of all TAH-t patient records in the INTERMACS Registry to confirm acceptability of treatment for bi-ventricular failure.
Time Frame: Three and Six Months Post-TAH-t Implant
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 as ordered by the CMS National Coverage Decisions which requires enrollment of Medicare patients in approved studies for evidence development.
Three and Six Months Post-TAH-t Implant

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Comparison of Adverse Event Rates
Time Frame: Three and Six Months Post-TAH-t Implant or Study Endpoint, whichever occurs first.
To evaluate the incidence of adverse events (AEs). The AEs will follow the definitions in the INTERMACS Registry.
Three and Six Months Post-TAH-t Implant or Study Endpoint, whichever occurs first.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

SynCardia Systems. LLC

Investigators

  • Principal Investigator: Francisco Arabia, MD, Banner University Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2013

Primary Completion (Anticipated)

December 1, 2022

Study Completion (Anticipated)

July 1, 2023

Study Registration Dates

First Submitted

August 6, 2013

First Submitted That Met QC Criteria

August 6, 2013

First Posted (Estimate)

August 9, 2013

Study Record Updates

Last Update Posted (Actual)

October 23, 2020

Last Update Submitted That Met QC Criteria

October 21, 2020

Last Verified

October 1, 2020

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • RA-409
  • Data Collection via INTERMACS (Registry Identifier: INTERMACS Registry)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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