Clinical Trial Considerations in Cerebral Protection for TAVR Patients – An Examination of Study Design, Endpoints and Imaging Methods

Clinical Trials, Life Sciences, Medical Device, Medical Device Clinical Trials, Pharmaceutical,
  • Wednesday, April 26, 2017

This complimentary webinar examines embolic protection devices and the potential impact these may have on TAVR patients and clinical studies.

Transcatheter aortic valve replacement (TAVR) or implantation (TAVI) demonstrably changed the treatment of high-risk patients with severe aortic stenosis, particularly those at high risk for surgical replacement of the aortic valve. However, greater acceptance of TAVR also raised concerns of complications, particularly increased risks for stroke or neurological and cognitive impairments from embolic events. The entry of embolic protection devices (EPD) into the European market, with designs that deflect or collect potentially damaging micro-debris associated with TAVR, presents an evolving risk-reduction safety strategy to manage patients with frail health or existing comorbidities.

This webinar explores the potential for EPDs as well as factors Novella Clinical and Medical Metrics believe sponsors should consider when developing or using EPDs in clinical trials.

  • Cerebral embolic protection and current State of the Art
  • Device performance and outcomes
  • Role of imaging in study outcome assessment
  • Considerations for clinical trial design

Learning Objectives:

  • Gain an understanding of the latest research and clinical outcomes of ongoing EPD studies
  • Learn the new definition of stroke and silent stroke
  • Understand appropriate use of DW-MRI and what parameters to assess
  • Learn how to select measurable endpoints to address efficacy and safety
  • Recognize the most efficient regulatory pathway to approval
  • Understand critical trial design considerations, including site selection, training, patient enrollment and pre-screening


Alan B. Lumsden, MD, ChB, RVT, FACS, Medical Director, Medical Metrics

Dr. Alan Lumsden is the medical director for Medical Metrics and a faculty member at Houston Methodist. Dr. Lumsden has developed an international reputation as a leader in the field of endovascular surgery. He has clinical and research expertise in stent graft treatment of thoracic and abdominal aortic aneurysms, stenting and endarterectomy in carotid arterial disease, renovascular hypertension, aortoiliac occlusive disease, mesenteric vascular and minimally invasive therapy in venous disease. Dr. Lumsden also conducts FDA-mandated training for surgeons nationwide in a carotid stenting simulator housed at the Houston Methodist DeBakey Heart and Vascular Center.

Dr. Lumsden’s research interests include developing novel minimally invasive methods of therapy and preventing restenosis. Dr. Lumsden’s academic career began at Emory University in Atlanta, Georgia where he completed his postdoctoral training and served as a Collaborative Scientist in the Division of Pathobiology and Immunology at the Yerkes Primate Center

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Zsolt Garami, MD, Director of Vascular Imaging, Medical Metrics

Dr. Zsolt Garami is the director of imaging for Medical Metrics and a faculty member at Houston Methodist. Dr. Garami has a clinical background in radiology and is EU board certified in that specialty. He has also received further specialization in intracranial ultrasound in Europe and the United States. In recent years, Dr. Garami has become a nationally recognized leader in transcranial doppler (TCD) imaging.

Dr. Garami´s research focuses on understanding and treating intracranial flow disturbances that cause stroke. He has numerous publications on the monitoring of the cerebral vasculature during vascular procedures such as coronary artery bypass grafting, and carotid artery surgery. His current studies aim to reveal critical patterns of distal intracranial embolization in LVAD patients.

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Richelle Massey, Senior Director, Project Management, Medical Device & Diagnostic Division, Novella Clinical

Richelle Massey provides strategic leadership and program management oversight for Novella Clinical’s Medical Device & Diagnostic Division. Mrs. Massey has more than 11 years of medical device and clinical trial management experience including clinical trial strategy for CLIII type devices, enrollment, execution, vendor management, and regulatory approval. Mrs. Massey has held several leadership positions within Clinical Project Management and Regulatory Affairs at CardioKinetix and Guidant Corporation/Abbott Vascular where she supported programs for drug-eluting stents and bioresorbable scaffolds. Mrs. Massey received her Bachelors in Marketing from Santa Clara University and her M.B.A. from the University of Phoenix.

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Who Should Attend?

This webinar is intended for medical device professionals who oversee cardiovascular device development and clinical research in North America and Europe. Attendees may include:

  • VP/Director of Clinical Operations / Outsourcing / Procurement / Project Management / Study Management / Regulatory Affairs
  • Cardiovascular division leaders

Xtalks Partners

Novella Clinical

Novella Clinical, a Quintiles company, is a global, full-service clinical research organization specializing in cardiovascular medical device and diagnostic clinical trials. Headquartered in Research Triangle Park, NC, Novella provides the experience and insight to bring devices and diagnostics to market on time and budget. For more information, visit

Medical Metrics, Inc.

Medical Metrics, Inc. (MMI) is an ISO 9001:2008-certified provider of independent imaging core lab services for clinical trials of medical devices, drugs, and biologics. We partner with clinical trial sponsors to conduct comprehensive imaging evaluations of novel treatments for cardiovascular, musculoskeletal, and neurological disorders. For more information, please visit

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