Current challenges for clinical trials of cardiovascular medical devices

• Published in: International journal of cardiology Vol. 175; no. 1; pp. 30 - 37
• Main Authors: Zannad, Faiez, Stough, Wendy Gattis, Piña, Ileana L, Mehran, Roxana, Abraham, William T, Anker, Stefan D, De Ferrari, Gaetano M, Farb, Andrew, Geller, Nancy L, Kieval, Robert S, Linde, Cecilia, Redberg, Rita F, Stein, Kenneth, Vincent, Alphons, Woehrle, Holger, Pocock, Stuart J
• Format: Journal Article
• Language: English
• Published: Shannon Elsevier Ireland Ltd 15.07.2014; Elsevier
• Subjects: Biological and medical sciences; Biomedical Research; Biomedical Research - standards; Biomedical Research - trends; Cardiology and cardiovascular system; Cardiology. Vascular system; Cardiovascular; Cardiovascular devices; Cardiovascular Diseases; Cardiovascular Diseases - epidemiology; Cardiovascular Diseases - therapy; Clinical trial; Device Approval; Device Approval - standards; Equipment Design; Equipment Design - standards; Equipment Design - trends; Heart; Human health and pathology; Humans; Life Sciences; Medical Device Legislation; Medical Device Legislation - trends; Medical sciences; Medicin och hälsovetenskap; Product Surveillance, Postmarketing; Product Surveillance, Postmarketing - standards; Product Surveillance, Postmarketing - trends; Randomized Controlled Trials as Topic; Research design; FDA; OPC; Cardiovascular devices; Device approval; optimal medical therapy; LVEF; IDE; PRO; prospective open with blinded evaluation; SCD-HeFT; patient reported outcomes; left ventricular ejection fraction; New York Heart Association; STICH; EMA; Clinical trial; PROBE; Food and Drug Administration; CEC; NYHA; CE; health-related quality of life; E.U; Sudden Cardiac Death in Heart Failure Trial; Conformité Européenne; investigational device exemption; Surgical Treatment for Ischemic Heart Failure; European Union; OMT; United STATES; HRQOL; Research design; U.S; Clinical Events Committee; European Medicines Agency; objective performance criteria; Design; Goal; Scientific research; Cardiovascular disease; Medical device; Circulatory system; Cardiology; Current
• ISSN: 0167-5273; 1874-1754; 1874-1754
• DOI: 10.1016/j.ijcard.2014.05.021

Abstract Several features of cardiovascular devices raise considerations for clinical trial conduct. Prospective, randomized, controlled trials remain the highest quality evidence for safety and effectiveness assessments, but, for instance, blinding may be challenging. In order to avoid bias and not confound data interpretation, the use of objective endpoints and blinding patients, study staff, core labs, and clinical endpoint committees to treatment assignment are helpful approaches. Anticipation of potential bias should be considered and planned for prospectively in a cardiovascular device trial. Prospective, single-arm studies (often referred to as registry studies) can provide additional data in some cases. They are subject to selection bias even when carefully designed; thus, they are generally not acceptable as the sole basis for pre-market approval of high risk cardiovascular devices. However, they complement the evidence base and fill the gaps unanswered by randomized trials. Registry studies present device safety and effectiveness in day-to-day clinical practice settings and detect rare adverse events in the post-market period. No single research design will be appropriate for every cardiovascular device or target patient population. The type of trial, appropriate control group, and optimal length of follow-up will depend on the specific device, its potential clinical benefits, the target patient population and the existence (or lack) of effective therapies, and its anticipated risks. Continued efforts on the part of investigators, the device industry, and government regulators are needed to reach the optimal approach for evaluating the safety and performance of innovative devices for the treatment of cardiovascular disease.