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

21. Oktober 2020 aktualisiert von: 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.

Studienübersicht

Status

Anmeldung auf Einladung

Bedingungen

Intervention / Behandlung

Studientyp

Beobachtungs

Einschreibung (Voraussichtlich)

500

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

  • Kind
  • Erwachsene
  • Älterer Erwachsener

Akzeptiert gesunde Freiwillige

Nein

Studienberechtigte Geschlechter

Alle

Probenahmeverfahren

Wahrscheinlichkeitsstichprobe

Studienpopulation

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

Beschreibung

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.

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Beobachtungsmodelle: Fallkontrolle
  • Zeitperspektiven: Querschnitt

Kohorten und Interventionen

Gruppe / Kohorte
Intervention / Behandlung
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.
Gerät: CSS Console TAH-t Patients
Comparison of two pneumatic drivers supporting the SynCardia TAH-t.
Andere Namen:
  • 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.
Gerät: C2 Driver System TAH-t Patients
Comparison of two pneumatic drivers supporting the SynCardia TAH-t
Andere Namen:
  • 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.
Gerät: CSS Console TAH-t Patients
Comparison of two pneumatic drivers supporting the SynCardia TAH-t.
Andere Namen:
  • SynCardia
Gerät: C2 Driver System TAH-t Patients
Comparison of two pneumatic drivers supporting the SynCardia TAH-t
Andere Namen:
  • SynCardia

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Positive outcome rates at three months and six months Post TAH-t Implant (Concurrent Cohort)
Zeitfenster: 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)
Zeitfenster: 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

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Review of all TAH-t patient records in the INTERMACS Registry to confirm acceptability of treatment for bi-ventricular failure.
Zeitfenster: 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

Andere Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Comparison of Adverse Event Rates
Zeitfenster: 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.

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

SynCardia Systems. LLC

Ermittler

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

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn

1. Dezember 2013

Primärer Abschluss (Voraussichtlich)

1. Dezember 2022

Studienabschluss (Voraussichtlich)

1. Juli 2023

Studienanmeldedaten

Zuerst eingereicht

6. August 2013

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

6. August 2013

Zuerst gepostet (Schätzen)

9. August 2013

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

23. Oktober 2020

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

21. Oktober 2020

Zuletzt verifiziert

1. Oktober 2020

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Schlüsselwörter

Andere Studien-ID-Nummern

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

Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .

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