Galvanize Prospective/Retrospective Pulsed Electric Field Device Registry
Start Date
6/23/2025
Completion Date
12/31/2028
Summary
The goal of this observational registry is to assess the use and performance of Galvanize PEF technology in a real-world setting. The main questions it aims to answer are: * PEF utilization and performance * Monitor safety outcomes and inform future generation devices. Participants will undergo the PEF procedure and be followed per institutional standard of care.
Detailed Description
This is a multi-center, observational registry that follows patients for a total of 2 years from the date of the Pulsed Electric Field (PEF) procedure with the FDA cleared Galvanize Technology. Patients will be enrolled and followed prospectively or enrolled retrospectively with prospective, longitudinal follow up. Enrollment for this study will include up to 200 patients throughout the US who underwent or are scheduled to undergo PEF energy delivery.
Eligibility Criteria
Age Range: 18 years to 100 years
Interventions
PEF ablation
Conditions
Locations
Banner Health
Gilbert, Arizona 85234
United States
Eisenhower Medical Center
Rancho Mirage, California 92270
United States
NCH Baker
Naples, Florida 34102
United States
New York Presbyterian Langone Health
New York, New York 10016
United States
Duke University Hospital
Durham, North Carolina 27705
United States
Lankenau Institute for Medical Research (LIMR)
Wynnewood, Pennsylvania 19096
United States
AnMed Health
Anderson, South Carolina 29621
United States
UT Southwestern Medical Center
Dallas, Texas 75390
United States
Methodist Hospital
San Antonio, Texas 78229
United States
University of Texas-Tyler
Tyler, Texas 75708
United States
West Virginia University
Morgantown, West Virginia 26506
United States