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.
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.
Study Type
OBSERVATIONAL
Enrollment
1,000
Pulsed Electric Field (PEF) Ablation per institutional standard of care
Eisenhower Medical Center
Rancho Mirage, California, United States
RECRUITINGNew York Presbyterian Langone Health
New York, New York, United States
RECRUITINGDuke University Hospital
Durham, North Carolina, United States
RECRUITINGAnesthesia Type Usage for PEF Procedure
Anesthesia type usage
Time frame: PEF procedure
PEF Target Location
PEF procedural target location
Time frame: PEF procedure
PEF Target Size
PEF target size (cm)
Time frame: PEF procedure
Incidence of SAEs
Incidence of SAEs (Registry device and/or procedure related)
Time frame: within 30 days of PEF energy delivery
Unanticipated [not listed in the Instructions for Use (IFU)] adverse events
Unanticipated \[not listed in the Instructions for Use (IFU)\] adverse events (device-related)
Time frame: within 30 days of PEF energy delivery
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Lankenau Institute for Medical Research (LIMR)
Wynnewood, Pennsylvania, United States
RECRUITING