title: Contemporary cardiovascular device clinical trials (trends and patterns 2001 to 2012).
abstract: Device uptake and development have progressed over the last decade, but few quantitative data exist examining the overall operating characteristics and temporal trends of these clinical trials. We performed a systematic analysis of all cardiovascular device clinical trials from 2001 to 2012 published in medical and cardiovascular journals with the 8 highest impact factors. Of the 1,224 identified cardiovascular clinical trials, 299 (24.4%) focused specifically on devices. Each trial included a median of 335 patients (162 to 745) recruited from a median of 14 sites (3 to 38) over a median enrollment duration of 1.9 years (1.2 to 3.3). Median enrollment rate was 1.1 patients/site/month (0.5 to 4.2). Most device trials targeted coronary artery disease (55.2%), followed by arrhythmias (17.4%). Most were industry sponsored (53.6%) and included mortality as a primary end point (69.6%). The median number of patients (225 to 499, p <0.001 for trend) and enrolling sites (11 to 19, p = 0.07 for trend) increased from 2001 to 2012. During the study period, multinational enrollment grew and approached 50% (p = 0.03), whereas trials enrolling in North America exclusively decreased from 30% to 17% (p = 0.10 for trend). Approximately 70% of device trials met their primary end points; this rate did not significantly change over time. In conclusion, this descriptive study of the contemporary cardiovascular device clinical trials highlights recent trends toward larger, more international trial programs. These aggregate data may help inform future cardiovascular device development.
authors.affiliation: Department of Medicine, Massachusetts General Hospital, Harvard Medical School, Boston, Massachusetts. Electronic address: muthu@md.northwestern.edu.
authors.forename: Muthiah
authors.initials: M
authors.lastname: Vaduganathan
authors.affiliation: Division of Cardiology, Emory University, Atlanta, Georgia.
authors.forename: Ayman S
authors.initials: AS
authors.lastname: Tahhan
authors.affiliation: Center for Cardiovascular Innovation, Northwestern University Feinberg School of Medicine, Chicago, Illinois.
authors.forename: Stephen J
authors.initials: SJ
authors.lastname: Greene
authors.affiliation: Division of Cardiology, Emory University, Atlanta, Georgia.
authors.forename: Anita A
authors.initials: AA
authors.lastname: Kelkar
authors.affiliation: Division of Cardiology, Emory University, Atlanta, Georgia.
authors.forename: Vasiliki V
authors.initials: VV
authors.lastname: Georgiopoulou
authors.affiliation: Division of Cardiology, Emory University, Atlanta, Georgia.
authors.forename: Andreas P
authors.initials: AP
authors.lastname: Kalogeropoulos
authors.affiliation: Ahmanson-UCLA Cardiomyopathy Center, Ronald Reagan-UCLA Medical Center, Los Angeles, California.
authors.forename: Gregg C
authors.initials: GC
authors.lastname: Fonarow
authors.affiliation: Center for Cardiovascular Innovation, Northwestern University Feinberg School of Medicine, Chicago, Illinois.
authors.forename: Mihai
authors.initials: M
authors.lastname: Gheorghiade
authors.affiliation: Division of Cardiology, Stony Brook University, Stony Brook, New York.
authors.forename: Javed
authors.initials: J
authors.lastname: Butler
mesh_terms: D002309:Cardiology / Q000295:instrumentation* / Q000639:trends*; D002318:Cardiovascular Diseases / Q000628:therapy*; D002986:Clinical Trials as Topic; D004867:Equipment Design; D006801:Humans