Galvanize Prospective/Retrospective Pulsed Electric Field Device Registry

Galvanize Prospective/Retrospective Pulsed Electric Field Device Registry

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.

Inclusion Criteria:

1. Subject will undergo or has undergone PEF energy delivery utilizing Galvanize technology
2. Subject is expected to be available for follow-up per the enrolling physician's standard care practices
3. For prospective cohort, subject has a life expectancy of at least 3 months; for retrospective cohort, subject has completed at least three months of imaging following the PEF procedure
4. Signed informed consent is obtained, if required by IRB

Exclusion Criteria:

None