Will randomized trials detect random valve failure? Reflections on a recent FDA workshop.
Grunkemeier
G L
GL
St. Vincent Heart Institute, Portland, Oregon 97225.
D006350:Heart Valve Prosthesis; D006801:Humans; D011183:Postoperative Complications / Q000209:etiology / Q000517:prevention & control*; D011358:Product Surveillance, Postmarketing; D011474:Prosthesis Design; D011475:Prosthesis Failure; D011786:Quality Control; D016032:Randomized Controlled Trials as Topic / Q000379:methods*; D014481:United States; D014486:United States Food and Drug Administration