Purpose of this Study
In this study, you will have a heart procedure called an ablation using a special system called the nsPFA Cardiac Surgery System. After the procedure, you will have follow up visits at one month, three months, six months, and twelve months. Around each visit, you will wear a heart monitor to track your heart rhythm and use a phone app to share information. The study team will also collect information about your medicines and your health during the study.
Who Can Participate?
Eligibility
People can join this study if they have had atrial fibrillation and are scheduled to have planned heart surgery that is not an emergency. They cannot join if they have a pacemaker, an artificial heart valve, kidney failure, or a long term lung disease called chronic obstructive pulmonary disease.
Age Range
18-85
Sex/Genders
Male (cisgender)
Female (cisgender)
Non-binary or gender fluid
Transgender male
Transgender female
Looking for Healthy Participants
No
What is Involved?
Description
The purpose of this study is to find out if a medical system called the CellFX nsPFA Cardiac Surgery System is safe and works well to treat a heart rhythm problem called atrial fibrillation. Researchers want to learn how well this system helps fix the irregular heartbeat and keeps patients safe during and after treatment.
Locations
Duke University Hospital
Visit Timing
Weekdays
Compensation
Yes
Spanish Materials Available
No
Study Details
Full Title
Pulse Biosciences’ CellFX nanosecond Pulsed Field Ablation (nsPFA) Cardiac Surgery Clamp System for treatment of Atrial Fibrillation (AF) during concomitant cardiac surgery
Principal Investigator
Adam
Williams
Protocol Number
PRO00119255
Phase
N/A
Enrollment Status
Open to Enrollment