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Initial Safety and Performance of the CellFX® nsPFA™ Cardiac Surgery System for the Treatment of Atrial Fibrillation
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.
This study is a prospective, multicenter, single arm, non-randomized, feasibility study. Adult subjects who are clinically indicated for a concomitant cardiac surgical procedure will undergo left pulmonary vein, roof and floor ablations to form a left atrial posterior box. All subjects will return to the hospital between 60-120 days post-surgical ablation procedure to undergo a cardiac electrophysiology study with electroanatomical mapping to assess electrical isolation of the pulmonary veins and left atrial posterior wall
Age
18 - 85 years
Sex
ALL
Healthy Volunteers
No
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
Start Date
July 31, 2024
Primary Completion Date
December 31, 2026
Completion Date
December 31, 2027
Last Updated
January 12, 2026
30
ESTIMATED participants
CellFX® nsPFA™ Cardiac Surgery System
DEVICE
Lead Sponsor
Pulse Biosciences, Inc.
Collaborators
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and ConditionsNCT06409156