Conclusions:
The present findings suggest an excellent safety and performance profile
for the novel 28mm cryoablation system, with safety and effectiveness
comparable to other ablation therapy. Additionally, the development of a
variable sized balloon may further increase safety and effectiveness of
PVI cryoablation. Considering recent findings that support early rhythm
control, single shot technologies, such as cryoballoon ablation, may see
increased utilization as first line treatment for PAF.
Acknowledgments: The Authors would like to acknowledge the
Investigators of FROzEN AF, Beth Albrecht (BSC, Sci Comm), Binh Tran
(BSC, RD), and Torri Schwartz (BSC, Statistics) as well as supporting
clinic staff and patients, without whom this work would not have been
possible.
Funding: This study was funded by Boston Scientific
Data Availability: The data from this clinical trial may be
made available to other researchers in accordance with Boston
Scientific’s Data Sharing Policy
(http://www.bostonscientific.com/en-US/data-sharing-requests.html).