NCT06959121

CellFX® Nanosecond Pulsed Field Ablation (nsPFA)™ Cardiac Surgery Clamp System to Treat Atrial Fibrillation

Pulse Biosciences' CellFX nsPFA Cardiac Surgery Clamp System for the Treatment of Atrial Fibrillation During Concomitant Cardiac Surgery

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 135 (estimated)
• Sponsor: Pulse Biosciences, Inc. · Industry
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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).

Conditions

• Atrial Fibrillation
• Maze Procedure
• AF
• Ablation

Interventions

Type	Name	Description
DEVICE	CellFX® nsPFA™ Cardiac Surgery System	Participants will receive cardiac ablation with the CellFX® nsPFA™ Cardiac Clamp

Timeline

• Start date: 2025-10-23
• Primary completion: 2027-04-01
• Completion: 2028-12-01
• First posted: 2025-05-06
• Last updated: 2026-01-12

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated device study