His Bundle Pacing 360 Degrees-FDA's Perspective to the Future of HBP (Presenter: Kimberly A. Selzman, MD, MPH, FHRS)

FDA's Perspective to the Future of HBP (Presenter: Kimberly A. Selzman, MD, MPH, FHRS)

Video Transcription

Video Summary

In this presentation, Dr. Roz Kazmersky from the FDA discusses the perspective of the FDA on the future of his bundle pacing. His bundle pacing was proposed over 50 years ago as a research method for studying electrophysiology and hemodynamics. It wasn't until 30 years later that permanent his bundle pacing was used in patients. The FDA's role is to ensure the safety and effectiveness of devices for his bundle pacing. They believe that the future of his bundle pacing lies in demonstrating its ability to resynchronize the ventricles. However, they also emphasize the importance of clinical equipoise and the need for large clinical efforts to answer unanswered questions. The FDA is willing to provide assistance in gaining approval for trials and reviewing trial designs.

Meta Tag

Lecture ID 7173

Location Room 155

Presenter Kimberly A. Selzman, MD, MPH, FHRS

Role Invited Speaker

Session Date and Time May 09, 2019 4:30 PM - 6:00 PM

Session Number S-039

Keywords

FDA

his bundle pacing

safety

resynchronize

clinical efforts