Current challenges for clinical trials of cardiovascular medical devices.

[1]  J. Georges [Nothing to disclose?]. , 2015, Annales de cardiologie et d'angeiologie.

[2]  Daniel B. Kramer,et al.  FDA approval of cardiac implantable electronic devices via original and supplement premarket approval pathways, 1979-2012. , 2014, JAMA.

[3]  P. Ponikowski,et al.  Clinical outcome endpoints in heart failure trials: a European Society of Cardiology Heart Failure Association consensus document , 2013, European journal of heart failure.

[4]  Ron Waksman,et al.  Overview of the 2011 Food and Drug Administration Circulatory System Devices Panel of the Medical Devices Advisory Committee Meeting on the CardioMEMS Champion Heart Failure Monitoring System. , 2013, Journal of the American College of Cardiology.

[5]  Unique device identification system. Final rule. , 2013, Federal register.

[6]  Deepak L. Bhatt,et al.  Catheter‐Based Renal Denervation for Resistant Hypertension: Rationale and Design of the SYMPLICITY HTN‐3 Trial , 2012, Clinical cardiology.

[7]  Jagmeet P. Singh,et al.  Multidisciplinary care of patients receiving cardiac resynchronization therapy is associated with improved clinical outcomes. , 2012, European heart journal.

[8]  T. Trikalinos,et al.  Do observational studies using propensity score methods agree with randomized trials? A systematic comparison of studies on acute coronary syndromes. , 2012, European heart journal.

[9]  W. Laskey,et al.  An Analysis of Implantable Cardiac Device Reliability. The Case for Improved Postmarketing Risk Assessment and Surveillance , 2012, American journal of therapeutics.

[10]  Pranav Loyalka,et al.  Use of an Intrapericardial, Continuous-Flow, Centrifugal Pump in Patients Awaiting Heart Transplantation , 2012, Circulation.

[11]  S. Hunt,et al.  A bridge far enough? , 2012, Circulation.

[12]  L. Mauri Why we still need randomized trials to compare effectiveness. , 2012, The New England journal of medicine.

[13]  Andrew S. Mugglin,et al.  Early Detection of an Underperforming Implantable Cardiovascular Device Using an Automated Safety Surveillance Tool , 2012, Circulation. Cardiovascular quality and outcomes.

[14]  Aaron S Kesselheim,et al.  Regulation of medical devices in the United States and European Union. , 2012, The New England journal of medicine.

[15]  N. Feder Medical devices--balancing regulation and innovation. , 2012, The New England journal of medicine.

[16]  J. Lozier More on hemophilia A induced by ipilimumab. , 2012, New England Journal of Medicine.

[17]  L. A. Bonet,et al.  ESC Guidelines for the diagnosis and treatment of acute and chronic heart failure 2012 , 2012, Turk Kardiyoloji Dernegi arsivi : Turk Kardiyoloji Derneginin yayin organidir.

[18]  Sanjay Kaul,et al.  Medical device regulatory reform: insights from the watchman left atrial appendage closure technology for stroke prophylaxis in atrial fibrillation. , 2011, Archives of internal medicine.

[19]  R. Redberg,et al.  Medical devices--balancing regulation and innovation. , 2011, The New England journal of medicine.

[20]  D. Challoner,et al.  Medical devices and health--creating a new regulatory framework for moderate-risk devices. , 2011, The New England journal of medicine.

[21]  D. Rowland,et al.  Impact of QRS duration on clinical event reduction with cardiac resynchronization therapy: meta-analysis of randomized controlled trials. , 2011, Archives of internal medicine.

[22]  Mitchell W Krucoff,et al.  Clinical evaluation of cardiovascular devices: principles, problems, and proposals for European regulatory reform. Report of a policy conference of the European Society of Cardiology. , 2011, European heart journal.

[23]  Stuart J Pocock,et al.  Transcatheter versus surgical aortic-valve replacement in high-risk patients. , 2011, The New England journal of medicine.

[24]  Matthew Thompson,et al.  Medical device recalls and transparency in the UK , 2011, BMJ : British Medical Journal.

[25]  Michael E Matheny,et al.  Automated surveillance to detect postprocedure safety signals of approved cardiovascular devices. , 2010, JAMA.

[26]  Lisa A Bero,et al.  Strength of study evidence examined by the FDA in premarket approval of cardiovascular devices. , 2009, JAMA.

[27]  S. Russell,et al.  Advanced heart failure treated with continuous-flow left ventricular assist device. , 2009, The New England journal of medicine.

[28]  R. Platt,et al.  The new Sentinel Network--improving the evidence of medical-product safety. , 2009, The New England journal of medicine.

[29]  J. Matsumura,et al.  Premarket assessment of devices for treatment of critical limb ischemia: the role of Objective Performance Criteria and Goals. , 2009, Journal of vascular surgery.

[30]  Stefano Ghio,et al.  Randomized trial of cardiac resynchronization in mildly symptomatic heart failure patients and in asymptomatic patients with left ventricular dysfunction and previous heart failure symptoms. , 2008, Journal of the American College of Cardiology.

[31]  L. Burke,et al.  The Use of Patient‐Reported Outcome Measures in the Evaluation of Medical Products for Regulatory Approval , 2008, Clinical pharmacology and therapeutics.

[32]  P. Schwartz,et al.  Left cardiac sympathetic denervation for catecholaminergic polymorphic ventricular tachycardia. , 2008, The New England journal of medicine.

[33]  Gregory Campbell Statistics in the World of Medical Devices: The Contrast with Pharmaceuticals , 2008, Journal of biopharmaceutical statistics.

[34]  Lilly Q Yue,et al.  Statistical and Regulatory Issues with the Application of Propensity Score Analysis to Nonrandomized Medical Device Clinical Studies , 2007, Journal of biopharmaceutical statistics.

[35]  D. Mann Clinical Evaluation of the CorCap Cardiac Support Device in Patients With Dilated Cardiomyopathy , 2005, The Annals of thoracic surgery.

[36]  U. S. Department of Health and Human Services FDA Cen Research,et al.  Guidance for industry: patient-reported outcome measures: use in medical product development to support labeling claims: draft guidance , 2006, Health and quality of life outcomes.

[37]  G. Grunkemeier,et al.  Prosthetic heart valves: Objective Performance Criteria versus randomized clinical trial. , 2006, The Annals of thoracic surgery.

[38]  Bram D. Zuckerman,et al.  FDA perspective on clinical trial design for cardiovascular devices. , 2006, The Annals of thoracic surgery.

[39]  A. Moskowitz,et al.  Progress versus precision: challenges in clinical trial design for left ventricular assist devices. , 2006, The Annals of thoracic surgery.

[40]  A. Hoes,et al.  Guidelines for the diagnosis and treatment of chronic heart failure: executive summary (update 2005): The Task Force for the Diagnosis and Treatment of Chronic Heart Failure of the European Society of Cardiology. , 2005, European heart journal.

[41]  Douglas L Packer,et al.  Amiodarone or an implantable cardioverter-defibrillator for congestive heart failure. , 2005, The New England journal of medicine.

[42]  Kenneth F Schulz,et al.  Blinding in randomised trials: hiding who got what , 2002, The Lancet.

[43]  E. Antman Cardiovascular Therapeutics: A Companion to Braunwald's Heart Disease , 2002 .

[44]  M C Oz,et al.  Long-term use of a left ventricular assist device for end-stage heart failure. , 2001, The New England journal of medicine.

[45]  R. Lilford,et al.  Are randomized clinical trials good for us (in the short term)? Evidence for a "trial effect". , 2001, Journal of clinical epidemiology.

[46]  S Hulley,et al.  Randomized trial of estrogen plus progestin for secondary prevention of coronary heart disease in postmenopausal women. Heart and Estrogen/progestin Replacement Study (HERS) Research Group. , 1998, JAMA.

[47]  Igor Sartori,et al.  Empirical Evidence of Bias. Dimensions of Methodological Quality Associated with Estimates of Treatment Effects in Controlled Trials , 1996 .

[48]  R. J. Hayes,et al.  Empirical evidence of bias. Dimensions of methodological quality associated with estimates of treatment effects in controlled trials. , 1995, JAMA.

[49]  B. Brent,et al.  Coronary artery bypass surgery in patients with left ventricular dysfunction. , 1986, The American journal of medicine.