Table 1.

 Characteristics of published trials on high risk cardiovascular devices. Figures are numbers (percentage) unless stated otherwise

	All studies (n=86)	Pivotal studies* (n=66)
Mean (range) time to publication (months) from FDA premarket approval	6.5 (−58-90)	7.9 (–58-90)
Industry funded	62 (71)	50 (76)
Source of funding not specified	24 (28)	16 (24)
Author conflicts disclosed	56 (65)	43 (65)
Multiple trials presented in pooled fashion	6 (7)	5 (8)

*Study was classified as pivotal if it was only one included in summary, multicenter randomized controlled trial, or explicitly noted in summary as being pivotal study.