Relevant Experience

Dr. Mason's Experience Relevant to Cardiac Safety Consultation

Investigator in Early Phase Development

Investigator in early phase development of several antiarrhythmic drugs (tocainide, encainide, flecainide, amiodarone, primenol, sotalol, acebutalol, N-acetylprocainamide, diltiazem, imipramine, and bethanidine) and devices (Intermedics antitachycardia device series, Intec AICD, Medtronic implantable hemodynamic monitor).

Principal Investigator

Principal Investigator of multinational, NIH-funded clinical trials: ESVEM (Electrophysiologic Study Vs. Electrocardiographic Monitoring), MTT (the US Myocarditis Treatment Trial), and SCOR (Specialized Center of Research in Sudden Death).

Data and Safety Monitoring Boards

Member and Chair of Data and Safety Monitoring Boards for NIH-funded clinical trials: Member, Digitalis Mortality Trial; Chair, Antiarrhythmic Effects of N-3 Fatty Acids; Chair, Fatty Acid Arrhythmia Trial; Member, Periodontal Intervention in Cardiac Events; Chair, Resuscitation Consortium; Member, ResQ Trial; Member, VEST Trial; Member, Siren Emergency Care Clinical Trials Network; Member, NIAID-DMID-SMC (23-0024).

Electrocardiography Standards Setting Committees

Chair, ECG-Self Assessment Program, American College of Cardiology (ACC); Chair, ACC ECG Exam; Member, ACC Electrocardiography/Electrophysiology Committee; Member, American Heart Association Electrocardiography Standardization Committee. Co-author of ACC/AHA Guidelines for clinical intracardiac electrophysiologic studies, Guidelines for implantation of cardiac pacemakers and antiarrhythmia devices, and ACC/AHA clinical competence statement on electrocardiography and ambulatory electrocardiography.

Sponsor Support at FDA Meetings

Multiple teleconference and face-to-face meetings with FDA on behalf of pharmaceutical companies since 1985.

Core ECG Laboratory

Medical Director, Covance Cardiac Safety Service, 2003–2007; Chief Medical Officer, Spaulding Clinical Research; consultant to pharma sponsors on drug development strategy, clinical trial design, expert analysis of cardiac safety data, and interaction with FDA.

Medical Device Developer

Co-founder of Kardiatec, S.A., a medical device company developing the PULVAD, a ventricular assist device based upon the principle of counterpulsation. Co-inventor, Spaulding Electrocardiograph.