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Review Article | Volume 3 Issue 1 (, 1997) | Pages 53 - 58
Sample size requirements for evaluating heart valves with constant risk events
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St. Vincent Heart Institute, Sisters of Providence in Oregon, Portland 97225.
Under a Creative Commons license
PMID : -8162217
Published
Jan. 19, 1994
Abstract

A method is described for computing sample size requirements for a clinical study of a new heart valve, according to the guidance document recently revised by the FDA. The FDA requirements specify a one-sample hypothesis test in which the complication rates for the study valve are compared to fixed values determined from previous experience with approved devices. These values, which can differ for different complications and for mechanical or tissue valve types, are called OPC's (Objective Performance Criteria). The method described, using the Poisson distribution, provides a simple formula for computing the valve-years required corresponding to any OPC. At the OPC level required by the FDA guidelines (1.2%/year), the minimum follow-up necessary is about 800 valve-years.

 

 

How to cite: Grunkemeier, G. L., Johnson, D. M., & Naftel, D. C. (1994). Sample size requirements for evaluating heart valves with constant risk events. The Journal of heart valve disease3(1), 53–58.

 

 

 

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