The objective of this study is to demonstrate initial safety and effectiveness of the CellFX nano-second Pulsed Field Ablation (nsPFA or nano-PFA) 360 Catheter Endocardial Ablation System in treating subjects with atrial fibrillation.
This study is a prospective, non-randomized, open labelled, single-arm first-in-human (FIH) feasibility study to evaluate the initial clinical safety and device performance of the nano-PFA 360 Catheter Endocardial Ablation System for the treatment of atrial fibrillation. Enrolled subjects will be followed for up to 12 months post-nano PFA 360 Catheter Ablation. All subjects will undergo an electroanatomical mapping procedure post-ablation to evaluate immediate pulmonary vein isolation (PVI) and at 3 months post-index procedure to assess electrical isolation of the pulmonary veins.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
60
The CellFX nano-PFA 360 Endocardial Ablation Catheter System includes the nano-pFA 360 Endocardial Ablation Catheter, CellFX Console, switcher box/adapter, and sensing cable. The System is a proprietary endocardial catheter system designed for use in cardiac electrophysiology procedures for the treatment of arrhythmias, including atrial fibrillation. The nano-PFA 360 Catheter ablates cardiac tissue using nonthermal nano-second pulses of electrical energy. Nanosecond Pulsed Field Ablation (nsPFA or nano-PFA) is a cell-specific, nonthermal ablation technology that delivers nanosecond-duration pulses of high-amplitude electrical energy to tissue via bipolar electrodes. The pulses disrupt the ability of the cell and internal organelles to maintain cellular homeostasis by creating nanopores in lipid membranes, ultimately leading to regulated cell death (RCD).
Hartcentrum Hasselt Research Center /Jessa Hospital
Hasselt, Belgium
ACTIVE_NOT_RECRUITINGNa Homolce Hospital
Prague, Czechia
RECRUITINGPoliclinico Tor Vergata Hospital
Roma, Italy
RECRUITINGRate of primary safety major adverse events (MAEs)
The primary safety endpoint includes major adverse events (MAEs) specifically related to the device or ablation procedure for the following * Asymptomatic Cerebral Embolism * Arterioesophageal Fistula * Bleeding Requiring Transfusion * Cardiac Perforation/Tamponade * Death * Esophageal Injury Resulting in Perforation * Myocardial Infarction * Pericarditis Requiring Intervention or Hospitalization * Phrenic Nerve Injury/Diaphragmatic Paralysis * Pulmonary Edema/Respiratory Insufficiency * Pulmonary Vein Stenosis (≥70% diameter reduction) * Stroke or Transient Ischemic Attack * Vagal Nerve Injury Resulting in Esophageal Dysmotility or Gastroparesis * Vascular Access Complication Requiring Intervention
Time frame: Within 30 days post-ablation procedure
Proportion of participants achieving acute procedural success.
Acute procedural success is achieving entrance block of the pulmonary veins
Time frame: Immediately post-ablation procedure
Proportion of participants reporting one or more significant adverse events (SAEs)
Safety related to the reporting one or more SAEs for each follow-up interval as described. * Atrio-esophageal fistula (up to 3-month visit) * Pulmonary Vein (PV) stenosis (up to 3-month visit) * Subjects presenting with Primary SAEs up to the 12-month post- procedure follow-up * Subjects presenting with any AEs or SAEs up to the 12-month post- procedure follow-up
Time frame: Within 12 months post-ablation procedure
Proportion of participants achieving long-term technical success
Long-term technical success is defined as electrical isolation of the pulmonary veins (PVI) assessed during an electroanatomical mapping procedure.
Time frame: Within 3 months post-ablation procedure
Proportion of participants achieving treatment success
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Treatment success is defined by freedom from the following failures: 1. Recurrence of atrial fibrillation, atrial flutter, atrial tachycardia (AF/AFL/AT) as evidenced by episodes ≥ 30 secs on transtelephonic monitoring (TTM), Holter monitoring, or continuously 12-lead electrocardiogram (ECG) 2. Cardioversion for atrial fibrillation (AF) /atrial flutter (AFL) / atrial tachycardia (AT) 3. Repeat ablation failure 4. Antiarrhythmic Drugs (AADs) failure 5. Surgical treatment for AF/AFL/AT after the index procedure
Time frame: Within 12 months post-ablation procedure