SynCardia Companion 2 Driver System Post Approval Study Protocol With INTERMACS™-Based Data Collection
NCT ID: NCT01919320
Last Updated: 2020-10-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
500 participants
OBSERVATIONAL
2013-12-31
2023-07-31
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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CASE_CONTROL
CROSS_SECTIONAL
Study Groups
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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.
CSS Console TAH-t Patients
Comparison of two pneumatic drivers supporting the SynCardia TAH-t.
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.
C2 Driver System TAH-t Patients
Comparison of two pneumatic drivers supporting the SynCardia TAH-t
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.
C2 Driver System TAH-t Patients
Comparison of two pneumatic drivers supporting the SynCardia TAH-t
CSS Console TAH-t Patients
Comparison of two pneumatic drivers supporting the SynCardia TAH-t.
Interventions
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C2 Driver System TAH-t Patients
Comparison of two pneumatic drivers supporting the SynCardia TAH-t
CSS Console TAH-t Patients
Comparison of two pneumatic drivers supporting the SynCardia TAH-t.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 is incarcerated.
ALL
No
Sponsors
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SynCardia Systems. LLC
INDUSTRY
Responsible Party
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Principal Investigators
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Francisco Arabia, MD
Role: PRINCIPAL_INVESTIGATOR
Banner University Medical Center
Other Identifiers
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Data Collection via INTERMACS
Identifier Type: REGISTRY
Identifier Source: secondary_id
RA-409
Identifier Type: -
Identifier Source: org_study_id
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