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

Launched by PULSE BIOSCIENCES, INC. · Jun 5, 2025

Keywords

ClinConnect Summary

This clinical trial is focused on testing a new treatment for a condition called atrial fibrillation (AF), which is a type of irregular heartbeat. The study aims to determine if the CellFX nano-second Pulsed Field Ablation (nsPFA) Catheter System is safe and effective for patients who have recurrent AF that doesn’t respond well to medication. The trial will include adults aged 18 to 85 who have been diagnosed with symptomatic paroxysmal or persistent AF. Specifically, eligible participants must have a history of AF episodes that either go away on their own or last longer than seven days, along with supporting medical documentation.

Participants in the trial will undergo a procedure using the new catheter system to help restore a normal heartbeat. They will need to provide informed consent and have a standard heart evaluation to ensure they are suitable candidates. Throughout the study, participants may have regular check-ups to monitor their progress and manage any potential risks. It’s important to note that certain medical conditions, such as previous heart surgery or specific heart measurements, may disqualify individuals from participating. Overall, this trial offers a potential new option for those struggling with AF despite other treatments.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• 1. A diagnosis of recurrent drug-resistant (Class I - IV) symptomatic paroxysmal or persistent AF:
• a. Symptomatic paroxysmal AF is defined as AF that terminates spontaneously or with intervention within seven (7) days of onset, documented by the following:
• • i. Physician's note indicating recurrent self-terminating AF prior to enrollment; AND
• • ii. At least one (1) ECG documented AF episode from any form of rhythm monitoring within six (6) months prior to enrollment
• • OR
• b. Symptomatic persistent AF, which is defined as continuous AF sustained beyond 7 days and less than 1 year, documented by the following:
• • i. physician's note indicating at least 1 symptomatic persistent AF episode occurring within 6 months prior to enrollment;
• • AND either
• • iia. any 24-hour continuous ECG recording documenting continuous AF within 6 months prior to enrollment; OR
• • iib. Two (2) ECGs from any form of rhythm monitoring taken at least 7 days apart, both showing continuous AF within 6 months prior to enrollment.
• • Age 18 through 85 years old (or older than 18 if required by local law)
• • Participant is willing and capable of providing Informed Consent
• • Received a standard cardiac work up and is an appropriate candidate for an investigational procedure as determined by study investigators
• Exclusion Criteria:
• • Left atrial diameter ≥5.5 cm (anteroposterior)
• * Any of the following within 3 months prior to enrollment:
• • 1. Any cardiac surgery
• • 2. Myocardial infarction
• • 3. Percutaneous Coronary Intervention (PCI) / Percutaneous Coronary Intervention (PTCA) or coronary artery stenting
• • 4. Unstable angina
• • 5. Pericarditis or symptomatic pericardial effusion
• * Any of the following within 6 months prior to enrollment:
• • 1. Any cerebral ischemic event (stroke or transient ischemic attack (TIA)
• • 2. History of thromboembolic event
• • Prior history of medical procedure involving instrumentation of the left atrium (previous ablation, atrial septal defect (ASD) closure, Left atrial appendage occlusion)
• • Planned Left Atrial Appendage (LAA) closure procedure, Transcatheter Aortic Valve Replacement (TAVR), Mitraclip, Atrial Septal Defect (ASD) or Patent Foramen Ovale (PFO) closure, Triclip or implant of an Implantable Loop Recorder (ILR), permanent pacemaker, biventricular pacemaker, or any implantable cardiac defibrillator (with or without biventricular pacing function) during or for any time during the follow-up period
• • Patient who is not on oral anticoagulation therapy for at least 3 weeks prior to the ablation procedure
• • Documented left atrial (LA) thrombus by imaging within 48 hours of the procedure.
• • Presence of a permanent pacemaker, biventricular pacemaker, or any type of implantable cardiac defibrillator (with or without biventricular pacing function).
• • Prior diagnosis of pulmonary vein stenosis
• • Valvular cardiac surgical/percutaneous procedure (e.g., ventriculotomy, atriotomy, and valve repair or replacement and presence of a prosthetic valve).
• • Moderate to severe mitral valve stenosis
• • More than moderate mitral regurgitation (i.e., 3+ or 4+ MR)
• • New York Heart Association (NYHA) Class III or IV congestive heart failure or documented left ventricular ejection fraction (LVEF) less than or equal to 35% measured by acceptable cardiac testing (e.g., TTE)
• • History of pulmonary hypertension with pulmonary systolic artery pressure \>50 mm Hg, severe Chronic Obstructive Pulmonary Disease or restrictive lung disease
• • Rheumatic heart disease
• • Contraindication to anticoagulation (i.e., Heparin, Dabigatran, Apixaban, Vitamin K Antagonists such as warfarin)
• • Active systemic infection
• • Hypertrophic cardiomyopathy
• • Atrial myxoma
• • Known reversible causes of AF, including but not limited to uncontrolled hyperthyroidism, severe untreated obstructive sleep apnea, and acute alcohol toxicity
• • History of abnormal bleeding and/or clotting disorder
• • Renal insufficiency with an estimated glomerular filtration rate (eGFR) \< 30 mL/min/1.73 m2, or any history of renal dialysis or renal transplant
• • History of severe chronic gastrointestinal problems involving the esophagus, stomach and/or untreated acid reflux
• • Solid organ or hematologic transplant, or currently being evaluated for an organ transplant
• • Any woman known to be pregnant or breastfeeding, or any woman of childbearing potential who is not on a reliable form of birth regulation method or abstinence
• • Other criteria, which the Investigator determines would make the patient unsuitable to participate (e.g. uncontrolled drug and/or alcohol addiction, congenital disease, fragility)
• • Body Mass Index (BMI) \> 40.0
• • Participants with any other significant uncontrolled or unstable medical condition (such as uncontrolled brady-arrhythmias, ventricular arrhythmias, hyperthyroidism or significant coagulation disorder)
• • Life expectancy less than one year
• • Current or anticipated participation in any other clinical study of a drug, device, or biologic during the duration of the study not pre-approved by the Sponsor
• • Unwilling or unable to comply fully with study procedures and follow-up