Transcatheter Aortic Valve Replacement With the Medtronic Transcatheter Aortic Valve Replacement System In Patients at Low Risk for Surgical Aortic Valve Replacement - Medtronic TAVR System In Patients at Low Risk for SAVR

Medtronic B.V.0 个研究点目标入组 60 人开始时间: 待定最近更新: 2024年4月23日

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•Heart Team consensus patient has < 3% predicted risk of mortality at 30 days
•* Severe aortic stenosis, defined as :
•* Symptomatic aortic stenosis
•Aortic valve area <= 1.0 cm2 (or aortic valve area index of <= 0.6 cm2/m2), OR
•gradient >= 40 mmHg, OR maximal aortic valve velocity >= 4.0 m/sec by
•transthoracic echocardiography
•* Asymptomatic aortic stenosis:
•- Very severe aortic stenosis with an aortic valve area of <=1.0 cm2 (or aortic
•valve area index of <=0.6 cm2/m2), AND maximal aortic velocity >= 5.0 m/sec,
•or mean gradient >= 60 mmHg by transthoracic echocardiography, OR
•- Aortic valve area of <=1.0 cm2 (or aortic valve area index of <=0.6 cm2/m2), AND
•a mean gradient >= 40 mmHg, or maximal aortic valve velocity >= 4.0 m/sec by
•transthoracic echocardiography, AND an exercise tolerance test that
•demonstrates a limited exercise capacity, abnormal BP response, or
•arrhythmia OR
•- Aortic valve area of <= 1.0 cm2 (or aortic valve area index of <= 0.6 cm2/m2),
•AND mean gradient >= 40 mmHg, or maximal aortic valve velocity >= 4.0 m/sec
•by transthoracic echocardiography, AND a left ventricular ejection fraction <
•* Indicated for SAVR with a bioprosthesis

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