128
Participants
Start Date
September 20, 2023
Primary Completion Date
November 5, 2025
Study Completion Date
December 5, 2025
Synaptic Cryoablation System
The Synaptic Cryo Balloon must be used to isolate all targeted pulmonary veins. Entrance block will be confirmed in all targeted pulmonary veins (PVs) after a 20-minute waiting period or provocative testing with adenosine or isoproterenol. Any additional ablation in the LA beside PV isolation is not allowed in this protocol. Additional ablation of the cavo-tricuspid isthmus (CTI) with a conventional market-approved RF catheter is allowed only in case a typical atrial flutter is documented in prior patient history or occurs during the case (either spontaneously or inducible).
Northwell Health - Lenox Hill Hospital, New York
VCU Pauley Heart Center, Richmond
Vanderbilt University Medical Center, Nashville
St. Luke's Mid America, Kansas City
St. Bernard's Heart & Vascular, Jonesboro
Christus Health Frances Hospital, Tyler
Banner University Medical Center, Phoenix
Dignity Health Arizona Research Enterprise, Phoenix
Cedars-Sinai Medical Center, Los Angeles
Mercy General Hospital, Sacramento
Synaptic Medical Corporation
INDUSTRY