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Regulatory Approval and Practice Guidelines Involving Cardiovascular Valve Devices: Determining the Right Evidentiary Bar.

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Randomized clinical trials (RCTs) are one of the foundations of evidence generation to determine the safety and effectiveness of new therapies in the cardiovascular device arena. They serve as the… Click to show full abstract

Randomized clinical trials (RCTs) are one of the foundations of evidence generation to determine the safety and effectiveness of new therapies in the cardiovascular device arena. They serve as the highest level of evidence for the comparison of the value of new therapies to existing standards. RCTs

Keywords: regulatory approval; involving cardiovascular; approval practice; guidelines involving; practice guidelines; cardiovascular valve

Journal Title: Journal of the American College of Cardiology
Year Published: 2020

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