Evaluation of Atrial Fibrillation and Other Arrhythmias within Clinical Trials and Clinical Practice

Clinical Trials, Life Sciences, Medical Device, Medical Device Clinical Trials, Pharmaceutical Regulation ,
  • April 28, 2015

The presenters in this webinar will discuss trends in continuous ecg monitoring and the implications for clinical trials of both medical device and therapies for cardiovascular, hematologic, metabolic and cns diseases, with an emphasis on atrial fibrillation and other arrhythmias.

Practicing Cardiologists, Scientists, Drug Developers and Regulators are starting to pay more attention to high throughput data related to cardiovascular health of patients. In clinical trials, ECG monitoring crosses all phases of clinical drug/device development (Phases I – IV). There is a need for both real-time and longer monitoring periods, particularly for assessment of Atrial Fibrillation, Atrial Flutter, Ventricular Fibrillation and Ventricular Tachycardia. Atrial Fibrillation (AF), the most common type of arrhythmia, is a serious health risk, particularly in the aging population. AF occurs if rapid, disorganized electrical signals cause the heart’s two upper chambers – the atria- to fibrillate. AF may happen rarely or every now and then, or it may become an ongoing or long-term heart problem that lasts for years. The costs in terms of treatment for AF are approaching $7Billion per year. Did you know that overall AF may be responsible for 15 – 20% of strokes? AF may be easy to ignore but the risk of heart failure or stroke make continuous monitoring an absolute necessity.

Arrhythmia and Syncope are two important conditions that should be optimally managed. In the case of AF, many occurrences do not lead to symptoms but still represent a threat to the patient due to the risk of cerebral and systemic embolism which not only applies to patients on drug therapy but also to those after catheter ablation. Both patients with AF and those with syncope have to be monitored.

Learn who is more likely to suffer from AF, what the symptoms are, what we in the clinical trials industry can do to help identify and treat AF and other heart rhythm irregularities with properly utilized continuous monitoring. BioTelemetry Research has profound professional expertise in Cardiovascular Disease testing, and Arrhythmia detection evaluation, in particular. World renowned experts in study design and analysis will provide insights into AF and how it can be continuously monitored as part of your clinical trial. Various types of monitoring devices will be covered, with a description of which type of continuous monitoring device best suits which type of clinical trial. The effectiveness of continuous monitoring in detecting heart rhythm events (arrhythmias, including AF) depends on its continuity and duration. New technologies and the future state of continuous monitoring will be explored.

Speakers

Polina Voloshko, MD, Chief Medical Officer, BioTelemetry Research

Dr. Voloshko has nearly 25 years of experience in ECG, ECHO and Holter research. Prior to joining the company, she was VP of Cardiovascular Clinical Services at the Ischemia Research and Education Foundation and Gentiae. Previously, Dr. Voloshko served as a research fellow at the University of California San Francisco (UCSF) and Chief of Cardiology at Riga City Hospital in Riga, Latvia, an affiliate of the Latvian Medical University. Board-certified in cardiology and internal medicine, Dr. Voloshko received her MD, magna cum laude, at the First St. Petersburg Medical School in Russia.

Wayne M. Derkac, MD, Vice President of Medical Affairs, BioTelemetry Inc.

Dr. Derkac joined BioTelemetry after a career practicing cardiothoracic surgery initially at Massachusetts General Hospital in Boston, MA and subsequently serving as President of Mid-Atlantic Cardiothoracic Surgeons at Sentara Heart Hospital in Norfolk, VA. He received his surgical training at Massachusetts General and Boston Children’s Hospital and was a Clinical Associate in the Surgery Branch, NHLBI at the National Institutes of Health in Bethesda, Maryland. Dr. Derkac attended Dartmouth College and received his M.D. from the Columbia University College of Physicians and Surgeons (AOA).

Who Should Attend?

This webinar will benefit professionals within biopharmaceutical research and medical device organizations, specifically those in the following roles:

  • Chief Medical Officer
  • VP Clinical Operations
  • VP Clinical Development
  • Director Clinical Operations
  • Director Clinical Development
  • Medical Writers

Xtalks Partners

BioTelemetry

As the research division of BioTelemetry Inc. (Nasdaq: BEAT), BioTelemetry Research, formerly Cardiocore, provides one of the world’s largest clinical data networks. Our broad range of Cardiac and Imaging services support both safety assessments and efficacy evaluations across all major therapeutic areas, through all phases of clinical trials, in every global region.

BioTelemetry Research offers a full range of centralized clinical trial testing modalities for both safety and endpoint evaluation. Cardiac includes ECG, Holter, TTM, MCOT, ECHO, and ABPM/BP. BioTelemetry Research provides Imaging services across therapeutic areas, including Oncology, CNS, Musculoskeletal, and Cardiovascular. Supported Imaging modalities include MRI, X-Ray, PET/CT, Bone Scintigraphy, and others.

Related Webinars

Sign Up or Login To Register for this Webinar

Interested in this webinar? Sign up to register for any upcoming or recorded webinar or if you’re already a member Login.

Sign Up