Acurate neo vs. Sapien 3 Transcatheter Heart Valve System in ... | 合法醫療器材資訊網

2020年10月17日—StudyDesign·Age≥75years·Aorticvalvearea<1cm·Clinicalsymptoms(>NewYorkHeartAssociationclassI,angina,syncope)·Inoperableor ...

Contribution To Literature:

Highlighted text has been updated as of September 17, 2022.

The SCOPE I trial showed that TAVR with the self-expanding Acurate neo valve did not meet criteria for noninferiority at 30 days compared with the balloon-expandable Sapien 3 valve among patients undergoing transfemoral TAVR.

Description:

The goal of the trial was to compare the safety and efficacy of transcatheter aortic valve replacement (TAVR) with the balloon-expandable Sapien 3 to the self-expanding Acurate neo valves among intermediate to high surgical risk patients with severe aortic stenosis undergoing transfemoral TAVR.

Study Design

Eligible patients were randomized in a 1:1 fashion to transfemoral TAVR with either Acurate neo (n = 372) or Sapien 3 (n = 367).

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ACURATE IDE | 合法醫療器材資訊網

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The goal of the ACURATE IDE Clinical trial is to evaluate the safety and effectiveness of the ACURATE neo2™ Transfemoral Aortic Valve System for ... Read More

ACURATE neo clinical trials | 合法醫療器材資訊網

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Top-down deployment provides hemodynamic stability and precise placement. Strong Clinical Outcomes. Unique self-expanding, supra-annular valve design ... Read More

Acurate neo vs. Sapien 3 Transcatheter Heart Valve System in ... | 合法醫療器材資訊網

2020年10月17日 — Study Design · Age ≥75 years · Aortic valve area <1 cm · Clinical symptoms (> New York Heart Association class I, angina, syncope) · Inoperable or ... Read More

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2020年10月15日 — SCOPE 2 Randomized Clinical Trial ... as proportions and compared by Fisher exact tests or an exact trend test for ordinal variables. Read More

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2020年10月15日 — At 1 year, the most common cause of cardiac death in the study cohort was adjudicated by the clinical event committee as heart failure.”. Read More

Transcatheter Aortic Valve Replacement (Tavr) Clinical Trials ... | 合法醫療器材資訊網

The purpose of this study is to see if , with the help of a new software program to find the aortic valve angles, accurate placement of a new valve can be ... Read More

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