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

21. oktober 2020 oppdatert av: 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.

Studieoversikt

Status

Påmelding etter invitasjon

Forhold

Intervensjon / Behandling

Studietype

Observasjonsmessig

Registrering (Forventet)

500

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

  • Barn
  • Voksen
  • Eldre voksen

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Prøvetakingsmetode

Sannsynlighetsprøve

Studiepopulasjon

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

Beskrivelse

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.

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Observasjonsmodeller: Case-Control
  • Tidsperspektiver: Tverrsnitt

Kohorter og intervensjoner

Gruppe / Kohort
Intervensjon / Behandling
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.
Enhet: CSS Console TAH-t Patients
Comparison of two pneumatic drivers supporting the SynCardia TAH-t.
Andre navn:
  • 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.
Enhet: C2 Driver System TAH-t Patients
Comparison of two pneumatic drivers supporting the SynCardia TAH-t
Andre navn:
  • 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.
Enhet: CSS Console TAH-t Patients
Comparison of two pneumatic drivers supporting the SynCardia TAH-t.
Andre navn:
  • SynCardia
Enhet: C2 Driver System TAH-t Patients
Comparison of two pneumatic drivers supporting the SynCardia TAH-t
Andre navn:
  • SynCardia

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Positive outcome rates at three months and six months Post TAH-t Implant (Concurrent Cohort)
Tidsramme: 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)
Tidsramme: 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

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Review of all TAH-t patient records in the INTERMACS Registry to confirm acceptability of treatment for bi-ventricular failure.
Tidsramme: 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

Andre resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Comparison of Adverse Event Rates
Tidsramme: 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.

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

SynCardia Systems. LLC

Etterforskere

  • Hovedetterforsker: Francisco Arabia, MD, Banner University Medical Center

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart

1. desember 2013

Primær fullføring (Forventet)

1. desember 2022

Studiet fullført (Forventet)

1. juli 2023

Datoer for studieregistrering

Først innsendt

6. august 2013

Først innsendt som oppfylte QC-kriteriene

6. august 2013

Først lagt ut (Anslag)

9. august 2013

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

23. oktober 2020

Siste oppdatering sendt inn som oppfylte QC-kriteriene

21. oktober 2020

Sist bekreftet

1. oktober 2020

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Andre studie-ID-numre

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

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

Kliniske studier på Bi-ventricular Failure

Kliniske studier på CSS Console TAH-t Patients

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Sponsorer og samarbeidspartnere

Medisinsk tilstand

Legemiddelintervensjoner

CROs by country

CROs in Togo

Forhold

Sjeldne sykdommer

Legemiddelintervensjoner

Kosttilskudd

Sponsor / samarbeidspartnere

Steder

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