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
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Clinical Trial Information
Trial Contact: Marquart, Vashnie; Ngo, George M.; Rodriguez, Jessica Marie; Cox, Caitlin L
Trial Phone: 321-843-1037 ; 3218439657 ; 3218413270 ; 321-841-1505
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IRB No: W20.028.03
Protocol Abbrev: ACURATE IDE
Principal Investigator: Vijaykumar S Kasi, PhD
Phase: Device: Significant Risk
Age Group: Adult
Secondary Protocol No: S2408
Treatment: Transcatheter Aortic Valve Replacement (TAVR)
Therapies Involved: Procedural
ClinicalTrials.gov ID: NTC03735667
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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.
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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.
