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

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ClinicalTrials.gov Identifier: NCT01919320
Recruitment Status : Unknown
Verified October 2020 by SynCardia Systems. LLC.
Recruitment status was:  Enrolling by invitation
First Posted : August 9, 2013
Last Update Posted : October 23, 2020
Sponsor:
Information provided by (Responsible Party):
SynCardia Systems. LLC

Study Description
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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.


Condition or disease Intervention/treatment
Bi-ventricular Failure Device: C2 Driver System TAH-t Patients Device: CSS Console TAH-t Patients

Study Design
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Study Type : Observational
Estimated Enrollment : 500 participants
Observational Model: Case-Control
Time Perspective: Cross-Sectional
Official Title: SynCardia Companion 2 Driver System Post Approval Study Protocol With INTERMACS™-Based Data Collection
Study Start Date : December 2013
Estimated Primary Completion Date : December 2022
Estimated Study Completion Date : July 2023
Groups and Cohorts
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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 Name: 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 Name: 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: C2 Driver System TAH-t Patients
Comparison of two pneumatic drivers supporting the SynCardia TAH-t
Other Name: SynCardia

Device: CSS Console TAH-t Patients
Comparison of two pneumatic drivers supporting the SynCardia TAH-t.
Other Name: SynCardia


Outcome Measures
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Primary Outcome Measures :
  1. 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.


  2. 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.



Secondary Outcome Measures :
  1. 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.


Other Outcome Measures:
  1. 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.


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01919320


Sponsors and Collaborators
SynCardia Systems. LLC
Investigators
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Principal Investigator: Francisco Arabia, MD Banner University Medical Center
More Information
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Responsible Party: SynCardia Systems. LLC
ClinicalTrials.gov Identifier: NCT01919320    
Other Study ID Numbers: RA-409
Data Collection via INTERMACS ( Registry Identifier: INTERMACS Registry )
First Posted: August 9, 2013    Key Record Dates
Last Update Posted: October 23, 2020
Last Verified: October 2020
Keywords provided by SynCardia Systems. LLC:
SynCardia
Total Artificial Heart
TAH-t