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ACURATE IDE: Transcatheter Replacement of Stenotic Aortic Valve through Implantation of ACURATE in Subjects InDicatEd for TAVR

ACURATE IDE: Transcatheter Replacement of Stenotic Aortic Valve through Implantation of ACURATE in Subjects InDicatEd for TAVR

  • Clinical Trial Information

    Trial Contact: Anthony, Susan; Tinetti, Meghan

    Trial Phone: 321.841.1505 ; 321.841.3682

  • IRB No: W20.028.03

    Protocol Abbrev: ACURATE IDE

    Principal Investigator: Vijaykumar S Kasi, MD

    Phase: Device: Significant Risk

    Age Group: Adult

    Secondary Protocol No: S2408

    Treatment: Transcatheter Aortic Valve Replacement (TAVR)

    Therapies Involved: Procedural

    ClinicalTrials.gov ID: NTC03735667

  • Objective

    The ACURATE Transfemoral Aortic Valve System is intended to improve aortic valve function in subjects with severe native aortic stenosis who are indicated for TAVR.

  • Key Eligibility

    •  Demographics including age and gender

    •  Medical history (general medical; cardiac [including previous cardiac surgery]; neurological, renal [including creatinine] and peripheral disease; and other medical conditions)

    •  Physical examination including weight and height o NYHA classification

    •  Current antiplatelet and other cardiovascular medications o Planned use of BAV (i.e., predilation)

    •  Risk assessments: Society of Thoracic Surgeons (STS) score, euroSCORE II, heart team assessment including an in-person evaluation by a center cardiac surgeon and any frailty assessments (detailed in next bullet). In the United States, CMS currently requires independent evaluations by 2 cardiac surgeons for reimbursement.