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).