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Treatment of PAF With the Synaptic System
Sponsor: Synaptic Medical Corporation
Summary
Enrolled subjects will be treated with the Synaptic Cryoablation System. Treatment will include cryoablation of the pulmonary veins to achieve PVI. All subjects will be followed for twelve (12) months after completion of the index ablation procedure.
Official title: Treatment of Symptomatic Drug Refractory Paroxysmal Atrial Fibrillation With the Synaptic Compliant Cryoablation Balloon and System
Key Details
Gender
All
Age Range
18 Years - 80 Years
Study Type
INTERVENTIONAL
Enrollment
128
Start Date
2023-09-20
Completion Date
2025-12-05
Last Updated
2025-09-11
Healthy Volunteers
No
Conditions
Interventions
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).
Locations (10)
Banner University Medical Center
Phoenix, Arizona, United States
Dignity Health Arizona Research Enterprise
Phoenix, Arizona, United States
St. Bernard's Heart & Vascular
Jonesboro, Arkansas, United States
Cedars-Sinai Medical Center
Los Angeles, California, United States
Mercy General Hospital
Sacramento, California, United States
St. Luke's Mid America
Kansas City, Missouri, United States
Northwell Health - Lenox Hill Hospital
New York, New York, United States
Vanderbilt University Medical Center
Nashville, Tennessee, United States
Christus Health Frances Hospital
Tyler, Texas, United States
VCU Pauley Heart Center
Richmond, Virginia, United States