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Trial · NCT04069156

Outcomes12

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

TypeOutcomeTime framePopulationUnitsMeasured as
PRIMARYPowered Primary Endpoint of Survival Free of Non-surgical Major Hemocompatibility Related Adverse Events12 Months
The primary end point was analyzed in the principal analysis population, which excluded patients with events occurring within 14 days after LVAD implantation to avoid counting surgical complications not attributed to the treatment.
ParticipantsCOUNT_OF_PARTICIPANTS
SECONDARYRates of Non-surgical Major Hemorrhagic EventsThrough Study Completion with a Median Follow up of 14 MonthsModified Intention to Treat Population (mITT)Event Per 100 Patient-YearNUMBER
SECONDARYRates of Bleeding EventsThrough Study Completion with a Median Follow up of 14 MonthsModified Intention to Treat Population (mITT)Event Per 100 Patient-YearNUMBER
SECONDARYRates of Non-surgical Major Thrombotic EventsThrough Study Completion with a Median Follow up of 14 MonthsModified Intention to Treat Population (mITT)Event Per 100 Patient-YearNUMBER
SECONDARYRates of StrokeThrough Study Completion with a Median Follow up of 14 MonthsModified Intention to Treat Population (mITT)Event Per 100 Patient-YearNUMBER
SECONDARYSurvival Rates24 MonthsModified Intention to Treat Population (mITT)Percentage of ParticipantsNUMBER
SECONDARYRisk of Non-Surgical Bleeding Events24 MonthsModified Intention to Treat PopulationPercentage of ParticipantsNUMBER
OTHER_PRE_SPECIFIEDRate of RehospitalizationThrough Study Completion with a Median Follow up of 14 MonthsModified Intention to Treat PopulationEvent Per 100 Patient-YearNUMBER
OTHER_PRE_SPECIFIEDEconomic Cost Implications - Total Estimated Cost for Bleeding Events (CMS Cost Basis)12 MonthsOnly US subjects were included in this analysisUSDNUMBER
OTHER_PRE_SPECIFIEDEconomic Cost Implications - Average Cost Per Bleeding Event12 MonthsOnly US subjects were included in this analysisUSDNUMBER
OTHER_PRE_SPECIFIEDEconomic Cost Implications - Average Cost Per Study Patient Over the First-year Post-implant12 MonthsOnly US subjects were included in this analysisUSDNUMBER
OTHER_PRE_SPECIFIEDEconomic Cost Implications - Cost of Bleeding Hospitalization for 1000 LVAD Implants Over the First-year Post-implant12 MonthsOnly US subjects were included in this analysisUSD/1000 implants/1 yearNUMBER

Source ClinicalTrials.govtrials-2026-11-12-0.5.0

Sources 3

  • ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
  • ClinicalTrials.govNo license stated
  • NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
  • ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
  • ClinicalTrials.govnone stated
  • NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

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