RecruitingNot ApplicableNCT06355063

CellFX® nsPFA™ Cardiac Surgery System to Treat Atrial Fibrillation

Initial Safety and Performance of the CellFX® nsPFA™ Cardiac Surgery System for the Treatment of Atrial Fibrillation

Sponsor

Pulse Biosciences, Inc.

Enrollment

30 participants

Start Date

Jul 31, 2024

Study Type

INTERVENTIONAL

Conditions

Surgery Atrial Fibrillation Ablation of Atrial Fibrillation Clamp Study

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.

Eligibility

Min Age: 18 YearsMax Age: 85 Years

Plain Language Summary

Simplified for easier understanding

This study tests a new device called the CellFX nsPFA Cardiac Surgery System for treating atrial fibrillation (an irregular heart rhythm) in patients who are already having open-heart surgery for another reason. The device uses very brief electrical pulses to destroy the abnormal heart tissue causing the irregular rhythm. **You may be eligible if...** - You are between 18 and 85 years old - You have a documented history of atrial fibrillation (irregular heart rhythm) within the past year - You are scheduled for open-heart surgery (such as valve repair or replacement, aortic aneurysm repair, or bypass surgery) - Your heart's pumping strength (ejection fraction) is at least 30% - You have a life expectancy of at least 5 years **You may NOT be eligible if...** - You have a pacemaker, defibrillator, or other implanted heart device - You have an artificial heart valve - You only have atrial fibrillation with no other reason for heart surgery - You have had prior heart surgery or a prior Maze procedure for atrial fibrillation - You have Wolff-Parkinson-White syndrome or other complex heart rhythm disorders Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICECellFX® 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.