美国心脏植入型电子器械上市前临床研究回顾
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摘要
本文简要回顾了美国食品药品监督管理局批准的波士顿科学、美敦力及圣犹达这3家全球最大的心脏植入型电子器械公司相关产品的上市前临床研究,重点关注了研究设计、终点选择及样本量,希望能对国内开展相应的工作提供参考。
We reviewed the pre-market clinical trials for cardiac implantable electronic devices in the United States manufactured by the three largest companies: Boston Scientific, Medtronic and St. Jude Medical. The review focused on clinical trial design, study endpoints and sample size, which would provide reference to similar endeavors in China.
We reviewed the pre-market clinical trials for cardiac implantable electronic devices in the United States manufactured by the three largest companies: Boston Scientific, Medtronic and St. Jude Medical. The review focused on clinical trial design, study endpoints and sample size, which would provide reference to similar endeavors in China.
引文
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[24]Bristow M R,Saxon L A,Boehmer J,et al.Cardia cresynchronization therapy with or without an implantable defibrillator in advanced chronic heart failure[J].New Engl JMed,2004,350(21):2140-2150.
[25]Moss AJ,Hall WJ,Cannom DS,et al.Cardiac-resynchronization therapy for the prevention of heart-failure events[J].New Engl JMed,2009,361(14):1329-1338.
[26]Tracy CM,Epstein AE,Darbar D,et al.2012 ACCF/AHA/HRS focused update incorporated into the ACCF/AHA/HRS2008 guidelines for device-based therapy of cardiac rhythm abnormalities:A report of the American College of Cardiology Foundation/American Heart Association Task Force on Practice Guidelines and the Heart Rhythm Society[J].J Am Coll Cardiol,2013,61(3):e6-75.
[2]Reddy VY,Doshi SK,Kar S,et al.5-year outcomes after left atrial appendage closure[J].J Am Coll Cardiol,2017,70(24):2964-2975.
[3]孙小磊,汪缨,张晖,等.3D打印技术在临床中的应用现状及展望[J].中国医疗设备,2017,32(1):99-102.
[4]Prinzen FW,Dagres N,Bollmann A,et al.Innovation in cardiovascular disease in Europe with focus on arrhythmias:current status,opportunities,roadblocks,and the role of multiple stakeholders[J].Europace,2018,20(5):733-738.
[5]Szymański P,Leggeri I,Kautzner J,et al.The new European regulatory framework for medical devices:opportunities for engagement by electrophysiologists[J].Europace,2018,20(6):902-905.
[6]Faris O,Shuren J.An FDA viewpoint on unique considerations for medical-device clinical trials[J].New Engl J Med,2017,376(14):1350-1357.
[7]Rathi VK,Krumholz HM,Masoudi FA,et al.Characteristics of clinical studies conducted over the total product life cycle of high-risk therapeutic medical devices receiving FDA premarket approval in 2010 and 2011[J].JAMA,2015,314(6):604.
[8]Wu Y,Li F,Fan Y,et al.A study of medical device regulation management model in Asia[J].Expert Rev Med Devic,2016,13(6):533-543.
[9]Mulpuru SK,Madhavan M,Mcleod CJ,et al.Cardiac pacemakers:function,troubleshooting,and management[J].J Am Coll Cardiol,2017,69(2):189-210.
[10]Madhavan M,Mulpuru SK,Mcleod CJ,et al.Advances and future directions in cardiac pacemakers[J].J Am Coll Cardiol,2017,69(2):211-235.
[11]Ploux S,Varma N,Strik M,et al.Optimizing implantable cardioverter-defibrillator remote monitoring[J].Pacing Clin Electrophysiol,2017,3(4):315-328.
[12]Tavazzi L.A brief overview of cardiac resynchronization therapy and its current use in clinical practice[J].Eur J Heart Fail,2017,19(10):1280-1283.
[13]Theuns DAMJ,Brouwer TF,Jones PW,et al.Prospective blinded evaluation of a novel sensing methodology designed to reduce inappropriate shocks by the subcutaneous implantable cardioverter-defibrillator[J].Heart Rhythm,2018,15(10):1515-1522.
[14]Weiss R,Knight BP,Gold MR,et al.Safety and efficacy of a totally subcutaneous implantable-cardioverter defibrillator[J].Circulation,2013,128(9):944-953.
[15]Della Rocca DG,Gianni C,Di Biase L,et al.Leadless pacemakers:State of the Art and Future Prespective[J].Cardiac Electrophysiol Clin,2018,10(1):17-29.
[16]Reddy VY,Exner DV,Cantillon DJ,et al.Percutaneous implantation of an entirely intracardiac leadless pacemaker[J].New Engl J Med,2015,373(12):1125-1135.
[17]Reynolds D,Duray G Z,O mar R,et al.Alead less intracardiac transcatheter pacing system[J].New Engl JMed,2016,374(6):533-541.
[18]Russo RJ,Costa HS,Silva PD,et al.Assessing the risks associated with MRI in patients with a pacemaker or defibrillator[J].New Engl J Med,2017,376(8):755-764.
[19]Nazarian S,Hansford R,Rahsepar AA,et al.Safety of magnetic resonance imaging in patients with cardiac devices[J].New Engl J Med,2017,377(26):2555-2564.
[20]Rome BN,Kramer DB,Kesselheim AS.FDA approval of cardiac implantable electronic devices via original and supplement premarket approval pathways,1979-2012[J].JAMA,2014,311(4):385.
[21]Moss AJ,Hall WJ,Cannom DS,et al.Improved survival with an implanted defibrillator in patients with coronary disease at high risk for ventricular arrhythmia[J].New Engl JMed,1996,335(26):1933-1940.
[22]Moss AJ,Zareba W,Hall WJ,et al.Prophylactic implantation of a defibrillator in patients with myocardial infarction and reduced ejection fraction[J].New Engl J Med,2002,346(12):877-883.
[23]Bardy GH,Lee KL,Mark DB,et al.Amiodarone or an implantable cardioverter-defibrillator for congestive heart failure[J].New Engl J Med,2005,352(3):225-237.
[24]Bristow M R,Saxon L A,Boehmer J,et al.Cardia cresynchronization therapy with or without an implantable defibrillator in advanced chronic heart failure[J].New Engl JMed,2004,350(21):2140-2150.
[25]Moss AJ,Hall WJ,Cannom DS,et al.Cardiac-resynchronization therapy for the prevention of heart-failure events[J].New Engl JMed,2009,361(14):1329-1338.
[26]Tracy CM,Epstein AE,Darbar D,et al.2012 ACCF/AHA/HRS focused update incorporated into the ACCF/AHA/HRS2008 guidelines for device-based therapy of cardiac rhythm abnormalities:A report of the American College of Cardiology Foundation/American Heart Association Task Force on Practice Guidelines and the Heart Rhythm Society[J].J Am Coll Cardiol,2013,61(3):e6-75.