Using a new catheter system to treat atrial fibrillation
Initial Safety and Performance of the CellFX® Nano-PFA 360 Catheter Endocardial Ablation System for the Treatment of Atrial Fibrillation
This study is testing a new catheter system to see if it safely helps people with paroxysmal atrial fibrillation feel better after treatment.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Pulse Biosciences, Inc. Industry-sponsored |
| Locations | 3 sites (Hasselt and 2 other locations) |
| Trial ID | NCT06696170 on ClinicalTrials.gov |
What this trial studies
This study evaluates the safety and effectiveness of the CellFX nano-second Pulsed Field Ablation (nsPFA) 360 Catheter Endocardial Ablation System in patients with paroxysmal atrial fibrillation. It is a prospective, non-randomized, open-label, single-arm feasibility study where participants will undergo the ablation procedure and be monitored for up to 12 months. Post-ablation, subjects will have electroanatomical mapping to assess the immediate and three-month outcomes of the procedure. The goal is to determine the initial clinical safety and performance of this innovative device.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 75 with documented paroxysmal atrial fibrillation who have failed at least one antiarrhythmic drug.
Not a fit: Patients with atrial fibrillation who have not experienced any episodes in the past year or those with significant heart failure may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could provide a safer and more effective treatment option for patients suffering from paroxysmal atrial fibrillation.
How similar studies have performed: While this approach is novel, similar studies using pulsed field ablation techniques have shown promising results in preliminary evaluations.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Subject must be ≥ 18 and ≤ 75 years of age on the day of enrollment * Subject is willing and capable of providing Informed Consent to undergo study procedures and participate in all examinations and follow-up visits and tests associated with this clinical study * Subjects with PAF who have had at least one AF episode documented within one (1) year prior to enrollment. Documentation may include ECG, transtelephonic monitor (TTM), Holter monitor (HM), or telemetry strip * Subjects who have failed at least one antiarrhythmic drug (AAD; class I or III, or AV nodal blocking agents such as beta blockers and calcium channel blockers) as shown by recurrent symptomatic AF, or intolerance to the AAD or AV nodal blocking agents * Antero-posterior left atrial diameter ≤ 5.5 cm as documented by transthoracic echocardiography (TTE) or computed tomography (CT) within 3 months prior to the procedure * Left ventricular ejection fraction ≥ 40% as documented by TTE within 12 months prior to the procedure * Received a standard cardiac work up and is an appropriate candidate for an investigational procedure as determined by the study investigators Exclusion Criteria: * Subject has an implantable electronic medical device. (i.e., pacemaker, ICD or CRT) or left atrial appendage device * Subject has a prosthetic heart valve * AF secondary to electrolyte imbalance, thyroid disease, or reversible or non-cardiac cause * AF episodes lasting \> 7 days * Previous ablation for AF * Subjects on amiodarone at any time during the past 3 months prior to enrollment * Prior history of pericarditis or pericarditis within 3 months based on the TTE examination * Prior history of rheumatic fever * Prior history of medical procedure involving instrumentation of the left atrium (previous ablation, atrial septal defect (ASD) closure, left atrial appendage occlusion) * History of severe chronic gastrointestinal problems involving the esophagus, stomach and/or untreated acid reflux * History of abnormal bleeding and/or clotting disorder * Contraindication to anticoagulation (i.e., Heparin, Dabigatran, Apixaban, Vitamin K Antagonists such as Warfarin) * Active malignancy or history of treated cancer within 24 months of enrollment * Clinically significant infection or sepsis on the day of index procedure with either fever, leukocytosis or requiring intravenous antibiotics * History of stroke or TIA within prior 6 months, or any prior intracranial hemorrhage or permanent neurological deficit * New York Heart Association (NYHA) class IIIb or IV congestive heart failure and/or any heart failure hospitalization within 3 months prior to enrollment * Body mass index \> 35 kg/m2 * Estimate glomerular filtration rate (eGFR) \< 60 mL/min/1.73 m2 or has ever received hemodialysis * History of untreated and serious hypotension, bradycardia or chronotropic incompetence * Any of the following within 3 months of enrollment: 1. Major surgery except for the index procedure 2. Myocardial infarction 3. Unstable angina 4. Percutaneous coronary intervention 5. Sudden cardiac death event 6. Left atrial thrombus that has not resolved as shown by TEE or CT * Solid organ or hematologic transplant, or currently being evaluated for an organ transplant * History of pulmonary hypertension with pulmonary systolic artery pressure \>50 mm Hg, severe Chronic Obstructive Pulmonary Disease or restrictive lung disease * Subjects 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 * Clinically significant psychological condition that in the physician's opinion would prohibit the subject's ability to meet the protocol requirements. * Females of childbearing potential who are nursing, pregnant, or planning to become pregnant during the study period * Other criteria, which the Investigator determines would make the patient unsuitable to participate (e.g. uncontrolled drug and/or alcohol addiction, congenital disease, fragility)
Where this trial is running
Hasselt and 2 other locations
- Hartcentrum Hasselt Research Center /Jessa Hospital — Hasselt, Belgium (Active_not_recruiting)
- Na Homolce Hospital — Prague, Czechia (Recruiting)
- Policlinico Tor Vergata Hospital — Roma, Italy (Recruiting)
Study contacts
- Study coordinator: William A. Knape
- Email: bknape@pulsebiosciences.com
- Phone: 510-906-4649
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.