Safety and Efficacy Comparison Of Two TAVI Systems in a ... | 合法醫療器材資訊網

2017年6月20日—Agrouporsubgroupofparticipantsinaclinicaltrialthat...aboutaclinicalstudyonClinicalTrials.govasaccurateandcurrent.

Transcatheter aortic valve implantation (TAVI) is an established and valuable treatment option for patients with severe symptomatic aortic stenosis and at high surgical risk for aortic valve replacement. The use of TAVI is rapidly expanding worldwide and its indications are widening into intermediate and lower risk populations. However, device comparisons by use of randomized trials are scarce in particular for newer generation transcatheter valves.

The Symetis ACURATE neo™, a self-expanding transcatheter valve delivered via transfemoral access, is a second-generation device that gained CE mark approval in June 2014.

The SCOPE-II trial will compare the safety and performance of the Symetis ACURATE neo™ with the self-expanding Medtronic Evolut R system, a widely used and well-established transcatheter heart valve, which obtained CE mark in 8NOV2006 and HAS approval on 13JAN2015.

ACURATE IDE | 合法醫療器材資訊網

2018年11月8日 — Absence of procedural mortality, correct positioning of a single transcatheter valve in the proper anatomical location, and intended ... Read More

Safety and Efficacy Comparison Of Two TAVI Systems in a ... | 合法醫療器材資訊網

2017年6月20日 — A group or subgroup of participants in a clinical trial that ... about a clinical study on ClinicalTrials.gov as accurate and current. Read More

Portico Re | 合法醫療器材資訊網

A group or subgroup of participants in a clinical trial that receives a specific ... about a clinical study on ClinicalTrials.gov as accurate and current. Read More

ACURATE IDE Trial Overview | 合法醫療器材資訊網

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

Learn more about Boston Scientific's Clinical Trials on the ACURATE neo aortic valve: SAVI-TF Post-Market Registry and ACURATE neo TA CE-Mark Study. Read More

ACURATE neo™ Aortic Valve System | 合法醫療器材資訊網

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

Comparison of Self | 合法醫療器材資訊網

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

Acurate Neo Fails to Match Results of CoreValve Evolut ... | 合法醫療器材資訊網

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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