Heart Valve Replacement: A Full-Team Approach for Operational Success

When considering the growing need for well-executed and conclusive trials within the valve replacement and repair arena, fully engaging the entire trial team is essential to achieving the required operational oversight. This is especially important when you consider that the TAVR (transcatheter aortic valve replacement) market is expected to approach $4 billion by 2020 1, 2 — and that demand for transcatheter mitral valve replacement devices is expected to grow to four times3 the TAVR market.

This webinar will take a deconstructed look at clinical trial requirements for valve replacements, defining a full-team approach, explaining its importance, and defining the factors that are critical to success in this field of research. Among them:

  • The team’s experience: globally, by region, and by country.
  • Regional regulatory requirements: accounting for differences between the FDA and European regulators.
  • Patient considerations (patients are, after all, important members of the research team).
  • Front-line experience: sites, investigators, nurses, and staff.
  • Project manager proficiency in clinical monitoring and data handling.
  • The valve study life cycle: applying the full team’s experience to planning milestones and other major decision points.

Takeaways from this webinar will help researchers at every point in the clinical trial process.

  1. Osnabrugge, R., et al. Disease prevalence and number of candidates for transcatheter aortic valve replacement. J Am Coll Cardiol. 2013:62(11):1002-1012.
  2. Global transcatheter aortic valve replacement market to generate close to USD 4 billion by 2020, says Technavio. Press release. February 3, 2016
  3. Stuart, M. Percutaneous mitral valve therapy: the next decade. START-UP, February 2012, Vol 17, No. 2. Elsevier Business Intelligence.