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www.pulsebiosciences.comPulse Biosciences, Inc. announced that enrollment for its clinical trial of the CellFX® Nanosecond Pulsed Field Ablation (nsPFA) system, aimed at treating Atrial Fibrillation, will commence in July 2025. The trial, identified as NCT06959121, will be a multicenter, two-arm, randomized, controlled study involving 165 adult subjects. Participants will either receive an ablation procedure alongside standard cardiac surgery or undergo standard surgery without ablation. The trial's primary endpoint focuses on assessing major adverse events within 30 days post-surgery, with anticipated completion by January 2027.
clinical trial start datePulse Biosciences, Inc. is expected to complete a clinical trial studying its CellFX® nsPFA™ Cardiac Surgery System for the treatment of atrial fibrillation on October 31, 2025. This prospective, multicenter feasibility study aims to evaluate the safety and effectiveness of the device in combination with cardiac surgery. The trial is currently recruiting, targeting an enrollment of 30 adult subjects who are indicated for concomitant cardiac surgical procedures. Participants will undergo ablation procedures, with follow-up electrophysiology studies scheduled between 60-120 days post-surgery to assess the outcomes of the treatment.
Clinical Trial CompletionPulse Biosciences, Inc. anticipates the completion of its clinical trial evaluating the CellFX® Nano-Pulsed Field Ablation 360 Catheter for treating paroxysmal atrial fibrillation on April 25, 2026. This trial is a first-in-human feasibility study assessing the device's safety and performance, with an enrollment of 60 participants. Subjects will be monitored for up to 12 months post-ablation, focusing on the evaluation of pulmonary vein isolation. This study is currently in the recruiting phase and commenced on July 25, 2024.
clinical trial completionPulse Biosciences, Inc. is expected to complete a clinical trial on January 1, 2027, assessing the efficacy of its CellFX® Nanosecond Pulsed Field Ablation (nsPFA)™ system for treating Atrial Fibrillation. The trial involves a two-arm, randomized, controlled approach, with 165 adult subjects undergoing a cardiac surgical procedure, either with or without ablation. Key safety endpoints include monitoring major adverse events post-procedure. The study's findings are anticipated to provide insights that could impact Pulse Biosciences' future product offerings in cardiac treatments.
Clinical Trial Completion