ACURATE NEO/TF Transcatheter Heart Valves and Non-inferiority Versus Medtronic CoreValve Systems

Summary

Participation Requirements

Description

The aim of this study is to evaluate the 30 day clinical and echo outcomes of Boston Scientific ACURATE NEO/TF TAVR and to compare them with outcomes in patients from the DIRECT trial treated with the Evolut TAVR system (Evolut R and Evolut PRO), aiming in showing non-inferiority of the ACURATE NEO/...

The aim of this study is to evaluate the 30 day clinical and echo outcomes of Boston Scientific ACURATE NEO/TF TAVR and to compare them with outcomes in patients from the DIRECT trial treated with the Evolut TAVR system (Evolut R and Evolut PRO), aiming in showing non-inferiority of the ACURATE NEO/TF device. Primary endpoint will be device success rate as defined by the VARC-2 criteria. Secondary endpoints involve the composite endpoint of early safety at 30 days, according to the VARC-2 definitions, specifically all cause mortality, cardiovascular mortality, stroke-TIA, acute kidney injury, conduction disturbances-arrhythmias, life-threatening or disabling bleeding, myocardial infarction, major vascular complication, valve related dysfunction requiring repeat procedure (BAV,TAVR,SAVR) as well as the echocardiographic outcomes and valve performance as designated by the VARC-2 definitions at 30 days. Study type: Observational, non-inferiority trial Estimated Enrollment: 80 patients Allocation: Non - randomized, all comers Primary Purpose: Treatment Observational Model: Case-Control Condition or disease: Aortic valve stenosis Intervention/Treatment: Device: Boston Scientific ACURATE neoTM transfemoral TAVI system Time Perspective: Prospective Participating centers: Henry Dunant Hospital (Athens, Greece), Hippokration Hospital (Athens, Greece), Silesian Center for Heart Diseases (Zabrze, Poland), Athens Naval Hospital (Athens, Greece). It is possible that the number of the participating center may change. Methods: Based on an anticipated incidence proportion of 90% for the primary composite endpoint of device success at 30 days, the total required sample size amounts to 80 patients. Patients treated with the Boston Scientific ACURATE NEO/TF system will be prospectively. All patients will be followed for at least 30 days. Event rates will be presented by Kaplan-Meier curves. On the basis of previous observations regarding TAVR success rate by VARC 2 definitions (DIRECT study), the study design uses a predefined non-inferiority margin of ? = 15% for the primary endpoint of device success rate at 30 days. The primary hypothesis is non-inferiority of ACURATE NEO/TF TAVR versus Evolut R and Evolut-Pro TAVR (based on the results of the DIRECT trial) for the primary endpoint at 30 days. The non-inferiority assumption will be tested at a one-sided significance level with a type I error rate (a=0.05). Non-inferiority will be met if the lower bound of the one-sided 95% confidence interval (CI) of the primary weighted difference of proportions endpoint (weighted average test-control) is over -15%. Pre-specified subgroup analyses will be conducted by using the appropriate interaction tests contrasting categories of mean gradient, aortic valve area (AVA) and left ventricular ejection fraction (>50% vs 50%).

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