RecruitingNot Applicable

NS-PFA Catheter Ablation of Paroxysmal Atrial Fibrillation With the Pulse Biosciences CellFX System

Czechia215 participantsStarted 2026-04-06

Plain-language summary

The objective of this study is to demonstrate the safety and effectiveness of the CellFX nano-second Pulsed Field Ablation (nsPFA) Cardiac Catheter Ablation System in treating recurrent, drug-resistant, symptomatic paroxysmal atrial fibrillation (AF).

Who can participate

Age range18 Years – 85 Years

SexALL

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Exclusion criteria

✕. Any cardiac surgery
✕. Myocardial infarction
✕. Percutaneous Coronary Intervention (PCI) / Percutaneous Coronary Intervention (PTCA) or coronary artery stenting
✕. Unstable angina
✕. Pericarditis or symptomatic pericardial effusion
✕. Any cerebral ischemic event (stroke or transient ischemic attack (TIA)
✕. History of thromboembolic event

What they're measuring

Proportion of participants with freedom from primary safety endpoint

Timeframe: Within 7 days, 30 days, and 6 months post-ablation procedure

Proportion of participants achieving freedom from treatment failure.

Timeframe: 6 months post-ablation

Trial details

NCT IDNCT07018596

SponsorPulse Biosciences, Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2026-10

Contact for this trial

Micki Weisman

510-906-4649 micki.weisman@pulsebiosciences.com

View on ClinicalTrials.gov More Atrial Fibrillation Paroxysmal trials