Identify yet to be published research that may have results available in the near future that could be relevant in the consideration of your application by MSAC (limiting these to the English language only). Please do not attach full text articles, this is just intended to be a summary. Type of Title of research (including any Short description of research (max 50 Website link to research (if available) Date design trial identifier if relevant) words) High-risk PCI (including protected PCI) 1. RCT, Coronary interventions in Currently recruiting patients to evaluate Suspended open label risk patients using a novel the use of HeartMate PHP with Impella® percutaneous leaft ventricular 2.5 as the active comparator, for both the support device (SHIELD II) elective and urgent indications NCT02468778 2. Prospective, PROTECTED PCI A Observational study measuring the Currently single-arm Prospective Clinical For composite rate of following recruiting. study Patients Undergoing Protected and post-procedural major Estimated primary Percutaneous Coronary adverse events at 90 days post index completion - Intervention With IMPELLA® 2.5 procedure. November 2020. System NCT02831881 Cardiogenic shock 1. RCT, Danish Cardiogenic Shock Trial Seeks to compare Impella® with Currently interventional, (DanShock) conventional circulatory support for recruiting. parallel cardiogenic shock following ST-elevation Expected to NCT01633502 assignment, myocardial infarct (MI). The trial has been complete in 2021 Phase 3 expanded to include German sites and aims to recruit 360 patients by 2021 with all cause mortality at 6 months as the primary outcome measure.
Identify yet to be published research that may have results available in the near future that could be relevant in the consideration of your application by MSAC (limiting these to the English language only). Please do not attach full text articles, this is just intended to be a summary. Type of design Title of research (including any trial identifier if relevant) Short description of research (max 50 words) Website link to research (if available) Date High-risk PCI (including protected PCI) 1. RCT, open label Coronary interventions in patients using a novel percutaneous leaft ventricular support device (SHIELD II) NCT02468778 Currently recruiting patients to evaluate the use of HeartMate PHP with Impella® 2.5 as the active comparator, for both the elective and urgent indications Suspended 2. Prospective, single-arm study PROTECTED PCI A Prospective Clinical For Patients Undergoing Protected Percutaneous Coronary Intervention With IMPELLA® 2.5 System NCT02831881 Observational study measuring the composite rate of following and post-procedural major adverse events at 90 days post index procedure. Currently recruiting. Estimated primary completion - November 2020. Cardiogenic shock 1. RCT, interventional, parallel assignment, Phase 3 Danish Cardiogenic Shock Trial (DanShock) NCT01633502 Seeks to compare Impella® with conventional circulatory support for cardiogenic shock following ST-elevation myocardial infarct (MI). The trial has been expanded to include German sites and aims to recruit 360 patients by 2021 with all cause mortality at 6 months as the primary outcome measure. Currently recruiting. Expected to complete in 2021 risk
MSAC_application_1523-application_form.docx