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CellFX® nsPFA™ Cardiac Surgery System to Treat Atrial Fibrillation
Sponsor: Pulse Biosciences, Inc.
Summary
This feasibility study will be conducted to demonstrate the initial safety and effectiveness of the CellFX® nsPFA™ Cardiac Clamp in performing a box lesion around the 4 pulmonary veins as an isolated procedure or as a part of a more extensive surgical ablation set in conjunction with concomitant cardiac surgical procedure.
Official title: Initial Safety and Performance of the CellFX® nsPFA™ Cardiac Surgery System for the Treatment of Atrial Fibrillation
Key Details
Gender
All
Age Range
18 Years - 85 Years
Study Type
INTERVENTIONAL
Enrollment
30
Start Date
2024-07-31
Completion Date
2027-12-31
Last Updated
2026-01-12
Healthy Volunteers
No
Interventions
CellFX® nsPFA™ Cardiac Surgery System
Adult patients presenting to the investigational center that are to undergo non-emergent concomitant cardiac surgical procedure(s), scheduled to be performed on cardiopulmonary bypass including open-heart surgery for one or more of the following: mitral valve repair or replacement, aortic valve repair or replacement, ascending aortic aneurysms, or coronary artery bypass procedures with history of documented atrial fibrillation within one year prior to enrollment will be evaluated for eligibility and participation in the study.
Locations (6)
Medical University of Vienna
Vienna, Austria
Academic Medical Center
Amsterdam, Netherlands
Catharina Hospital
Eindhoven, Netherlands
Maastricht University Medical Center+ (MUMC+)
Maastricht, Netherlands
St. Antonius Hospital
Nieuwegein, Netherlands
State Medical Institute of the Ministry of Interior Affairs and Administration
Warsaw, Poland