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

21 ottobre 2020 aggiornato da: 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.

Panoramica dello studio

Stato

Iscrizione su invito

Condizioni

Intervento / Trattamento

Tipo di studio

Osservativo

Iscrizione (Anticipato)

500

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

  • Bambino
  • Adulto
  • Adulto più anziano

Accetta volontari sani

No

Sessi ammissibili allo studio

Tutto

Metodo di campionamento

Campione di probabilità

Popolazione di studio

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

Descrizione

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.

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Modelli osservazionali: Caso di controllo
  • Prospettive temporali: Trasversale

Coorti e interventi

Gruppo / Coorte
Intervento / Trattamento
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.
Dispositivo: CSS Console TAH-t Patients
Comparison of two pneumatic drivers supporting the SynCardia TAH-t.
Altri nomi:
  • 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.
Dispositivo: C2 Driver System TAH-t Patients
Comparison of two pneumatic drivers supporting the SynCardia TAH-t
Altri nomi:
  • 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.
Dispositivo: CSS Console TAH-t Patients
Comparison of two pneumatic drivers supporting the SynCardia TAH-t.
Altri nomi:
  • SynCardia
Dispositivo: C2 Driver System TAH-t Patients
Comparison of two pneumatic drivers supporting the SynCardia TAH-t
Altri nomi:
  • SynCardia

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Positive outcome rates at three months and six months Post TAH-t Implant (Concurrent Cohort)
Lasso di tempo: 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)
Lasso di tempo: 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

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Review of all TAH-t patient records in the INTERMACS Registry to confirm acceptability of treatment for bi-ventricular failure.
Lasso di tempo: 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

Altre misure di risultato

Misura del risultato
Misura Descrizione
Lasso di tempo
Comparison of Adverse Event Rates
Lasso di tempo: 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.

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

SynCardia Systems. LLC

Investigatori

  • Investigatore principale: Francisco Arabia, MD, Banner University Medical Center

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio

1 dicembre 2013

Completamento primario (Anticipato)

1 dicembre 2022

Completamento dello studio (Anticipato)

1 luglio 2023

Date di iscrizione allo studio

Primo inviato

6 agosto 2013

Primo inviato che soddisfa i criteri di controllo qualità

6 agosto 2013

Primo Inserito (Stima)

9 agosto 2013

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

23 ottobre 2020

Ultimo aggiornamento inviato che soddisfa i criteri QC

21 ottobre 2020

Ultimo verificato

1 ottobre 2020

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Altri numeri di identificazione dello studio

  • RA-409
  • Data Collection via INTERMACS (Identificatore di registro: INTERMACS Registry)

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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