Sample Size Requirements for Clinical Trials of Transcatheter Valve Replacement and Valve Repair Devices

References

• Mylotte D , Osnabrugge RL , Windecker S , et al. Transcatheter aortic valve replacement in Europe: adoption trends and factors influencing device utilization. J Am Coll Cardiol . 2013;62:210–219. doi:10.1016/j.jacc.2013.03.074.
   PubMed Web of Science ®Google Scholar
• Tang GH , Lansman SL , Cohen M , et al. Transcatheter aortic valve replacement: current developments, ongoing issues, future outlook. Cardiol Rev . 2013;21:55–76. doi:10.1097/CRD.0b013e318283bb3d.
   Web of Science ®Google Scholar
• Tchetche D , Van Mieghem NM. New-generation TAVI devices: description and specifications. EuroIntervention . 2014;10(Suppl U):U90–U100. doi:10.4244/EIJV10SUA13.
   PubMedGoogle Scholar
• Figulla HR , Webb JG , Lauten A , Feldman T. The transcatheter valve technology pipeline for treatment of adult valvular heart disease. Eur Heart J . 2016;37:2226–2239. doi:10.1093/eurheartj/ehw153.
   PubMed Web of Science ®Google Scholar
• Market Monitors CV Pipeline . Transcatheter mitral valve technologies in development (by therapy type). Paris: EuroPCR; 19–23 May, 2014
   Google Scholar
• Holmes DR Jr. , Califf R , Farb A , et al. Overcoming the challenges of conducting early feasibility studies of medical devices in the United States. J Am Coll Cardiol . 2016;68:1908–1915. doi:10.1016/j.jacc.2016.07.769.
   PubMed Web of Science ®Google Scholar
• Bekelman JE , Li Y , Gross CP . Scope and impact of financial conflicts of interest in biomedical research: a systematic review. JAMA . 2003;289:454–465.
   PubMed Web of Science ®Google Scholar
• Baim DS , Donovan A , Smith JJ , et al. Medical device development: managing conflicts of interest encountered by physicians. Cath Cardiovasc Interv . 2007;69:655–664. doi:10.1002/ccd.21150.
   Web of Science ®Google Scholar
• Kramer DB , Xu S , Kesselheim AS . Regulation of medical devices in the United States and European Union. N Eng J Med . 2012;366:848–855. doi:10.1056/NEJMhle1113918.
   PubMed Web of Science ®Google Scholar
• Hwang TJ , Sokolov E , Franklin JM , Kesselheim AS . Comparison of rates of safety issues and reporting of trial outcomes for medical devices approved in the European Union and United States: cohort study. BMJ . 2016;353:i3323.
   PubMed Web of Science ®Google Scholar
• Stern AD , Kramer DB , Ouellet M , Kesselheim AS . Review times and adverse events for cardiovascular devices. Nat Eng . 2017. doi:10.1038/s41551-016-0013.
   Google Scholar
• Starr A , Edwards ML . Mitral replacement: clinical experience with a ball-valve prosthesis. Ann Surg . 1961;154:726–740.
   PubMed Web of Science ®Google Scholar
• Higgs R . Wrecking Ball: FDA Regulation of Medical Devices. In: Rottenberg S, ed. American Health Care: Government, Economic Processes, and the Public Interest. Washington, DC: Cato Institute; 1995.
   Google Scholar
• Johnson DM , Sapirstein W . FDA’s requirements for in-vivo performance data for prosthetic heart valves. J Heart Valve Dis . 1994;3:350–355.
   Google Scholar
• Gersh BJ , Fisher LD , Schaff HV , et al. Issues concerning the clinical evaluation of new prosthetic valves. J Thorac Cardiovasc Surg . 1986;91:460–466.
   PubMed Web of Science ®Google Scholar
• Grunkemeier GL , Johnson DM , Naftel DC . Sample size requirements for evaluating heart valves with constant risk events. J Heart Valve Dis . 1994;3:53–58.
   PubMedGoogle Scholar
• Grunkemeier GL , Starr A , Rahimtoola SH . Prosthetic heart valve performance: long-term follow-up. Curr Probl Cardiol . 1992;17:329–406.
   Web of Science ®Google Scholar
• Akins CW , Miller DC , Turina MI , et al. Guidelines for reporting mortality and morbidity after cardiac valve interventions. J Thorac Cardiovasc Surg . 2008;135:732–738. doi:10.1016/j.jtcvs.2007.12.002.
   PubMed Web of Science ®Google Scholar
• Guidance FRHVD . Food, Administration D. Version 4.1 . Washington, DC: US Department of Health and Human Services; 1994:1–134.
   Google Scholar
• Wu Y , Butchart EG , Borer JS , Yoganathan A , Grunkemeier GL . Clinical evaluation of new heart valve prostheses: update of objective performance criteria. Ann Thorac Surg . 2014;98:1865–1874. doi:10.1016/j.athoracsur.2014.05.006.
   Web of Science ®Google Scholar
• Head SJ , Mylotte D , Mack MJ , et al. Considerations and recommendations for the introduction of objective performance criteria for transcatheter aortic heart valve device approval. Circulation . 2016;133:2086–2093. doi:10.1161/CIRCULATIONAHA.115.020493.
   Web of Science ®Google Scholar
• Eypasch E , Lefering R , Kum C , Troidl H . Probability of adverse events that have not yet occurred: a statistical reminder. BMJ . 1995;311:619–620.
   PubMed Web of Science ®Google Scholar
• Hanley JA , Lippman-Hand A . If nothing goes wrong, is everything all right?: interpreting zero numerators. JAMA . 1983;249:1743–1745.
   PubMed Web of Science ®Google Scholar