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RECRUITING
NCT06355063
NA

CellFX® nsPFA™ Cardiac Surgery System to Treat Atrial Fibrillation

Sponsor: Pulse Biosciences, Inc.

View on ClinicalTrials.gov

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

DEVICE

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