Bi-ventricular FailureC2 PASNCT01919320
SynCardia Companion 2 Driver System Post Approval Study Protocol With INTERMACS™-Based Data Collection
An observational study of Bi-ventricular Failure, run by SynCardia Systems. LLC.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Bi-ventricular Failure
- What is being tested?
- C2 Driver System TAH-t Patients and CSS Console TAH-t Patients
- Type of treatment
- Medical device
- How many people
- 500 participants
- Where
- No sites listed yet
- Study dates
- Dec 2013to Jul 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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
Who may be able to join
- 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.
Who cannot join
- Patient or legal guardian has not signed an ICF for INTERMACS Registry participation, if required at the institution.
- Patient is incarcerated.
About this study
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.
Read more
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.
- Conditions
- Bi-ventricular Failure
- Being tested
- C2 Driver System TAH-t Patients, CSS Console TAH-t Patients
- Keywords
- SynCardia, Total Artificial Heart, TAH-t
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
C2 Driver System TAH-t PatientsDevice
Also called SynCardia
Comparison of two pneumatic drivers supporting the SynCardia TAH-t
CSS Console TAH-t PatientsDevice
Also called SynCardia
Comparison of two pneumatic drivers supporting the SynCardia TAH-t.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: CSS Console TAH-t Patients | |
| 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. Receives: Device: C2 Driver System TAH-t Patients | |
| 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. Receives: Device: C2 Driver System TAH-t Patients; Device: CSS Console TAH-t Patients |
What is being measured
The primary outcome is the main question the study is designed to answer.
Positive outcome rates at three months and six months Post TAH-t Implant (Concurrent Cohort)
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.
Measured: Three and Six Months Post-TAH-t Implant
Positive outcome rates at three months and six months Post TAH-t Implant (Cumulative Cohort)
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.
Measured: Three and Six Months Post-TAH-t Implant
Secondary outcomes (1)
Review of all TAH-t patient records in the INTERMACS Registry to confirm acceptability of treatment for bi-ventricular failure.
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.
Measured: Three and Six Months Post-TAH-t Implant
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2013 (estimated)
- Study startDec 2013
- Primary completionDec 2022 (estimated)
- Study completionJul 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bi-ventricular FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- SynCardia Systems. LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Francisco Arabia, MD, Principal investigator, Banner University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01919320
- Sponsor's protocol ID
- RA-409
- Other IDs
- Data Collection via INTERMACS
- Acronym
- C2 PAS
- Status last verified
- Oct 2020
- First submitted
- 6 Aug 2013
- Last updated
- 23 Oct 2020
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- SynCardia Companion 2 Driver System Post Approval Study Protocol With INTERMACS™-Based Data Collection
- ClinicalTrials.gov ID
- NCT01919320
- Acronym / sponsor ID
- C2 PAS / RA-409
- Conditions
- Bi-ventricular Failure
- Keywords
- SynCardia, Total Artificial Heart, TAH-t
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- SynCardia Systems. LLCIndustry (pharma, biotech, devices)
- Study start
- Dec 2013
- Primary completion
- Dec 2022 (estimated)
- Study completion
- Jul 2023 (estimated)
- First posted
- 9 Aug 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| CSS Console TAH-t Patients | – | Device: CSS Console TAH-t PatientsAll 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. |
| C2 Driver System TAH-t Patients | – | Device: C2 Driver System TAH-t Patients200 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. |
| All TAH-t Patient Records | – | Device: C2 Driver System TAH-t Patients, Device: CSS Console TAH-t PatientsAll records for TAH-t patients enrolled in the INTERMACS Registry will be reviewed to support Objective 2 of the protocol. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (2 listed)
- Patient or legal guardian has not signed an ICF for INTERMACS Registry participation, if required at the institution.
- Patient is incarcerated.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| C2 Driver System TAH-t PatientsAlso: SynCardiaComparison of two pneumatic drivers supporting the SynCardia TAH-t | Device | All TAH-t Patient Records, C2 Driver System TAH-t Patients |
| CSS Console TAH-t PatientsAlso: SynCardiaComparison of two pneumatic drivers supporting the SynCardia TAH-t. | Device | All TAH-t Patient Records, CSS Console TAH-t Patients |
Primary outcome
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.
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.
1 secondary outcome
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Oct 2020.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Francisco Arabia, MD principal investigator
Banner University Medical Center
Questions about this trial
What is this clinical trial studying?
An observational study of Bi-ventricular Failure, run by SynCardia Systems. LLC.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Oct 2020; AzTrials last refreshed its copy on 3 Nov 2026.