RecruitingNot ApplicableNCT06959121

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


Sponsor

Pulse Biosciences, Inc.

Enrollment

135 participants

Start Date

Oct 23, 2025

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 YearsMax Age: 85 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a new surgical device that uses very short, powerful electrical pulses (nanosecond pulsed field ablation) to treat atrial fibrillation (AF) — an irregular heartbeat — during heart surgery. The device delivers energy to the heart tissue to destroy the abnormal electrical pathways that cause AF, without the heat damage of older methods. **You may be eligible if...** - You are between 18 and 85 years old - You have documented atrial fibrillation (either intermittent/paroxysmal or persistent/long-standing) - You are scheduled for non-emergency heart surgery for another reason (such as valve repair or bypass) - You are willing to undergo AF treatment as part of the surgery and complete follow-up visits **You may NOT be eligible if...** - You have had a prior surgical or catheter-based ablation for AF - You have had a recent stroke or blood clot within the past 3 months - You have severe heart failure or other conditions making additional ablation too risky - You are pregnant 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

Participants will receive cardiac ablation with the CellFX® nsPFA™ Cardiac Clamp


Locations(2)

Adventist Heart Institute: Adventist Health St. Helena

St. Helena, California, United States

Cardiac Surgery Clinic | Frankel Cardiovascular Center

Ann Arbor, Michigan, United States

View Full Details on ClinicalTrials.gov

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NCT06959121


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