The primary objective of this Pivotal study is to demonstrate the safety and effectiveness of the Pulse Biosciences nsPFA™ Cardiac Surgery System in treating atrial fibrillation during concomitant cardiac surgical procedures.
The study design is a prospective, multicenter, non-randomized single arm study. Eligible adult subjects with paroxysmal or persistent/longstanding persistent AF who are eligible to participate will undergo a concomitant cardiac surgical procedure with CellFX nsPFA Cardiac Surgery System ablation and left atrial appendage exclusion or removal. The left atrial wall isolation will include left and right pulmonary vein isolation as well as isolation of the left atrial posterior wall through left atrial roof and floor lesions. The left atrial posterior wall isolation (PWI) can be formed by either allowing a closed LA epicardial only lesion encompassing the entire posterior wall of the left atrium or by a combined epicardial/endocardial approach when the left atrium is open. Primary effectiveness endpoint is freedom from any AF/AFL/AT lasting \> 30 seconds and freedom for use of new or increased dose of previously failed Class I or III antiarrhythmic drugs (AADs) prescribed to treat atrial arrhythmias following the 90-day blanking period through 6 months post the concomitant surgical and ablation procedure by a core lab. Primary safety endpoint is the incidence of acute major adverse events (MAEs), which includes death, stroke, myocardial infarction (MI), transient ischemic attack (TIA), or excessive bleeding (Bleeding Academic Research Consortium (BARC) 3b, 4, or 5) within 30 days post-concomitant surgical procedure. These events may be related to either the cardiac surgical procedure or the ablation procedure. All MAE events will be reviewed and adjudicated by an independent Clinical Events Committee (CEC).
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
135
Participants will receive cardiac ablation with the CellFX® nsPFA™ Cardiac Clamp
Adventist Heart Institute: Adventist Health St. Helena
St. Helena, California, United States
RECRUITINGCardiac Surgery Clinic | Frankel Cardiovascular Center
Ann Arbor, Michigan, United States
RECRUITINGFreedom from atrial fibrillation/atrial flutter/atrial tachycardia
Freedom from AF/AFL/AT of 30 seconds or greater duration and freedom for use of new or increased dose of previously failed Class I or III antiarrhythmic drugs (AADs) prescribed to treat atrial arrhythmias.
Time frame: 3-months through 6 months post-index procedure
Incidence of Treatment-Emergent Adverse Events
Rate of acute major adverse events (MAEs) which includes death, stroke, myocardial infarction (MI), and transient ischemic attack (TIA) or excessive bleeding (Bleeding Academic Research Consortium (BARC) 3b, 4 or 5).
Time frame: Within 30 days post-concomitant surgical procedure
Acute electrical isolation of the pulmonary veins
Acute electrical isolation of the left and right pulmonary veins and left atrial posterior wall by means of either intraoperative entrance or exit block testing
Time frame: Immediately post-ablation procedure
Freedom from atrial fibrillation/atrial flutter/atrial tachycardia
Freedom from AF/AFL/AT of 30 seconds and freedom from use of new or increased dose of previously failed Class I or III AADs prescribed to treat atrial arrhythmias
Time frame: Within 12 months post-ablation procedure
Patient-Reported Outcome Measures (PROMs) for quality of life assessing well-being across physical, mental, and social domains
Quality of Life (QoL) as measured using AFEQT and SF-12 (Physical Component Summary (PCS), Mental Component Summary (MCS) and General Health (GH))
Time frame: 6 and 12 months post-ablation procedure
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